Modular battery powered handheld surgical instrument with multiple magnetic position sensors

ABSTRACT

A system comprising a surgical instrument is disclosed. The surgical instrument includes a handle, a shaft, a plurality of magnets, a plurality of sensors configured to determine a distance away from one or more of the plurality of magnets, and a processor communicatively coupled to the plurality of sensors. The processor is configured to determine a three dimensional change in position of the shaft by computing a three dimensional change in position of the one or more magnets, using the change in the distances determined by the one or more plurality of sensors.

PRIORITY

This application claims the benefit of U.S. Provisional Application Ser.No. 62/279,635 filed Jan. 15, 2016 and U.S. Provisional Application Ser.No. 62/330,669, filed May 2, 2016, the contents of each of theseprovisional applications is incorporated herein by reference in theirentirety.

BACKGROUND

The present disclosure is related generally to surgical instruments andassociated surgical techniques. More particularly, the presentdisclosure is related to ultrasonic and electrosurgical systems thatallow surgeons to perform cutting and coagulation and to adapt andcustomize such procedures based on the type of tissue being treated.

Ultrasonic surgical instruments are finding increasingly widespreadapplications in surgical procedures by virtue of the unique performancecharacteristics of such instruments. Depending upon specific instrumentconfigurations and operational parameters, ultrasonic surgicalinstruments can provide simultaneous or near-simultaneous cutting oftissue and hemostasis by coagulation, desirably minimizing patienttrauma. The cutting action is typically realized by an-end effector, orblade tip, at the distal end of the instrument, which transmitsultrasonic energy to tissue brought into contact with the end effector.Ultrasonic instruments of this nature can be configured for opensurgical use, laparoscopic, or endoscopic surgical procedures includingrobotic-assisted procedures.

Some surgical instruments utilize ultrasonic energy for both precisecutting and controlled coagulation. Ultrasonic energy cuts andcoagulates by vibrating a blade in contact with tissue. Vibrating athigh frequencies (e.g., 55,500 times per second), the ultrasonic bladedenatures protein in the tissue to form a sticky coagulum. Pressureexerted on tissue with the blade surface collapses blood vessels andallows the coagulum to form a hemostatic seal. The precision of cuttingand coagulation is controlled by the surgeon's technique and adjustingthe power level, blade edge, tissue traction, and blade pressure.

Electrosurgical instruments for applying electrical energy to tissue inorder to treat and/or destroy the tissue are also finding increasinglywidespread applications in surgical procedures. An electrosurgicalinstrument typically includes a hand piece, an instrument having adistally-mounted end effector (e.g., one or more electrodes). The endeffector can be positioned against the tissue such that electricalcurrent is introduced into the tissue. Electrosurgical instruments canbe configured for bipolar or monopolar operation. During bipolaroperation, current is introduced into and returned from the tissue byactive and return electrodes, respectively, of the end effector. Duringmonopolar operation, current is introduced into the tissue by an activeelectrode of the end effector and returned through a return electrode(e.g., a grounding pad) separately located on a patient's body. Heatgenerated by the current flowing through the tissue may form hemostaticseals within the tissue and/or between tissues and thus may beparticularly useful for sealing blood vessels, for example. The endeffector of an electrosurgical instrument also may include a cuttingmember that is movable relative to the tissue and the electrodes totransect the tissue.

Electrical energy applied by an electrosurgical instrument can betransmitted to the instrument by a generator in communication with thehand piece. The electrical energy may be in the form of radio frequency(“RF”) energy. RF energy is a form of electrical energy that may be inthe frequency range of 200 kilohertz (kHz) to 1 megahertz (MHz). Inapplication, an electrosurgical instrument can transmit low frequency RFenergy through tissue, which causes ionic agitation, or friction, ineffect resistive heating, thereby increasing the temperature of thetissue. Because a sharp boundary is created between the affected tissueand the surrounding tissue, surgeons can operate with a high level ofprecision and control, without sacrificing un-targeted adjacent tissue.The low operating temperatures of RF energy is useful for removing,shrinking, or sculpting soft tissue while simultaneously sealing bloodvessels. RF energy works particularly well on connective tissue, whichis primarily comprised of collagen and shrinks when contacted by heat.

The RF energy may be in a frequency range described in EN60601-2-2:2009+A11:2011, Definition 201.3.218—HIGH FREQUENCY. Forexample, the frequency in monopolar RF applications may be typicallyrestricted to less than 5 MHz. However, in bipolar RF applications, thefrequency can be almost anything. Frequencies above 200 kHz can betypically used for monopolar applications in order to avoid the unwantedstimulation of nerves and muscles that would result from the use of lowfrequency current. Lower frequencies may be used for bipolarapplications if the risk analysis shows the possibility of neuromuscularstimulation has been mitigated to an acceptable level. Normally,frequencies above 5 MHz are not used in order to minimize the problemsassociated with high frequency leakage currents. Higher frequencies may,however, be used in the case of bipolar applications. It is generallyrecognized that 10 mA is the lower threshold of thermal effects ontissue.

A challenge of using these medical devices is the inability to fullycontrol and customize the functions of the surgical instruments. Itwould be desirable to provide a surgical instrument that overcomes someof the deficiencies of current instruments.

SUMMARY

In one aspect, the present disclosure provides a system comprising asurgical instrument. The surgical instrument comprises a handleassembly; a shaft coupled to the handle assembly; a plurality of magnetsfixedly coupled to the shaft; a plurality of sensors coupled to theshaft and each configured to determine a distance away from one or moreof the plurality of magnets; and a processor communicatively coupled tothe plurality of sensors; wherein: the shaft is configured to changeposition relative to a stationary reference plane; one or more of theplurality of magnets are configured to change position corresponding tothe changed position of the shaft; one or more of the plurality ofsensors are further configured to determine a change in the distances ofthe one or more of the plurality of magnets relative to the one or moreof the plurality of sensors as the one or more magnets change position;and the processor is configured to determine a three dimensional changein position of the shaft by computing a three dimensional change inposition of the one or more magnets, using the change in the distancesdetermined by the one or more plurality of sensors.

In another aspect, the present disclosure provides a surgical instrumentcomprising a plurality of magnets; a plurality of sensors configured todetermine a distance away from one or more of the plurality of magnets;and a processor communicatively coupled to the plurality of sensors,wherein the processor is configured to determine a three dimensionalchange in position of the surgical instrument by computing a threedimensional change in position of the one or more magnets, using thechange in the distances determined by the one or more plurality ofsensors.

In another aspect, the present disclosure provides a method ofcontrolling a surgical instrument. The method comprises a plurality ofmagnets, a plurality of sensors configured to determine a distance awayfrom one or more of the plurality of magnets, and a processorcommunicatively coupled to the plurality of sensors, the methodcomprising: determining, by the processor, a three dimensional change inposition of the surgical instrument by computing a three dimensionalchange in position of the one or more magnets, using the change in thedistances determined by the one or more plurality of sensors.

In addition to the foregoing, various other method and/or system and/orprogram product aspects are set forth and described in the teachingssuch as text (e.g., claims and/or detailed description) and/or drawingsof the present disclosure.

The foregoing is a summary and thus may contain simplifications,generalizations, inclusions, and/or omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is NOT intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteachings set forth herein.

In one or more various aspects, related systems include but are notlimited to circuitry and/or programming for effecting herein-referencedmethod aspects; the circuitry and/or programming can be virtually anycombination of hardware, software, and/or firmware configured to affectthe herein-referenced method aspects depending upon the design choicesof the system designer. In addition to the foregoing, various othermethod and/or system aspects are set forth and described in theteachings such as text (e.g., claims and/or detailed description) and/ordrawings of the present disclosure.

Further, it is understood that any one or more of thefollowing-described forms, expressions of forms, examples, can becombined with any one or more of the other following-described forms,expressions of forms, and examples.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, and featuresdescribed above, further aspects, and features will become apparent byreference to the drawings and the following detailed description.

FIGURES

The novel features of the various aspects described herein are set forthwith particularity in the appended claims. The various aspects, however,both as to organization and methods of operation may be betterunderstood by reference to the following description, taken inconjunction with the accompanying drawings as follows:

FIG. 1 is a diagram of a modular battery powered handheld ultrasonicsurgical instrument, according to an aspect of the present disclosure.

FIG. 2 is an exploded view of the surgical instrument shown in FIG. 1,according to an aspect of the present disclosure.

FIG. 3 is an exploded view of a modular shaft assembly of the surgicalinstrument shown in FIG. 1, according to aspect of the presentdisclosure.

FIG. 4 is a perspective transparent view of the ultrasonictransducer/generator assembly of the surgical instrument shown in FIG.1, according to aspect of the present disclosure.

FIG. 5 is an end view of the ultrasonic transducer/generator assembly,according to aspect of the present disclosure.

FIG. 6 is a perspective view of the ultrasonic transducer/generatorassembly with the top housing portion removed to expose the ultrasonicgenerator, according to aspect of the present disclosure.

FIG. 7 is a sectional view of the of the ultrasonic transducer/generatorassembly, according to aspect of the present disclosure.

FIG. 8 is an elevation view of an ultrasonic transducer/generatorassembly that is configured to operate at 31 kHz resonant frequency,according to one aspect of the present disclosure.

FIG. 9 is an elevation view of an ultrasonic transducer/generatorassembly that is configured to operate at 55 kHz resonant frequency,according to one aspect of the present disclosure.

FIGS. 10A and 10B illustrate a shifting assembly that selectivelyrotates the ultrasonic transmission waveguide with respect to theultrasonic transducer and urges them towards one another, according toone aspect of the present disclosure.

FIG. 11 is a schematic diagram of one aspect of an ultrasonic drivecircuit shown in FIG. 4 suitable for driving an ultrasonic transducer,according to one aspect of the present disclosure.

FIG. 12 is a schematic diagram of the transformer coupled to theultrasonic drive circuit shown in FIG. 11, according to one aspect ofthe present disclosure.

FIG. 13 is a schematic diagram of the transformer shown in FIG. 12coupled to a test circuit, according to one aspect of the presentdisclosure.

FIG. 14 is a schematic diagram of a control circuit, according to oneaspect of the present disclosure.

FIG. 15 shows a simplified block circuit diagram illustrating anotherelectrical circuit contained within a modular ultrasonic surgicalinstrument, according to one aspect of the present disclosure.

FIG. 16 shows a battery assembly for use with the surgical instrument,according to one aspect of the present disclosure.

FIG. 17 shows a disposable battery assembly for use with the surgicalinstrument, according to one aspect of the present disclosure.

FIG. 18 shows a reusable battery assembly for use with the surgicalinstrument, according to one aspect of the present disclosure.

FIG. 19 is an elevated perspective view of a battery assembly with bothhalves of the housing shell removed exposing battery cells coupled tomultiple circuit boards which are coupled to the multi-lead batteryterminal in accordance with one aspect of the present disclosure.

FIG. 20 illustrates a battery test circuit, according to one aspect ofthe present disclosure.

FIG. 21 illustrates a supplemental power source circuit to maintain aminimum output voltage, according to one aspect of the presentdisclosure.

FIG. 22 illustrates a switch mode power supply circuit for supplyingenergy to the surgical instrument, according to one aspect of thepresent disclosure.

FIG. 23 illustrates a discrete version of the switching regulator shownin FIG. 22 for supplying energy to the surgical instrument, according toone aspect of the present disclosure.

FIG. 24 illustrates a linear power supply circuit for supplying energyto the surgical instrument, according to one aspect of the presentdisclosure.

FIG. 25 is an elevational exploded view of modular handheld ultrasonicsurgical instrument showing the left shell half removed from a handleassembly exposing a device identifier communicatively coupled to themulti-lead handle terminal assembly in accordance with one aspect of thepresent disclosure.

FIG. 26 is a detail view of a trigger portion and switch of theultrasonic surgical instrument shown in FIG. 25, according to one aspectof the present disclosure.

FIG. 27 is a fragmentary, enlarged perspective view of an end effectorfrom a distal end with a jaw member in an open position, according toone aspect of the present disclosure.

FIG. 28 illustrates a modular shaft assembly and end effector portionsof the surgical instrument, according to one aspect of the presentdisclosure.

FIG. 29 is a detail view of an inner tube/spring assembly, according toone aspect of the present disclosure.

FIG. 30 illustrates a modular battery powered handheld combinationultrasonic/electrosurgical instrument, according to one aspect of thepresent disclosure.

FIG. 31 is an exploded view of the surgical instrument shown in FIG. 30,according to one aspect of the present disclosure.

FIG. 32 is a partial perspective view of a modular battery poweredhandheld combination ultrasonic/RF surgical instrument, according to oneaspect of the present disclosure.

FIG. 33 illustrates a nozzle portion of the surgical instrumentsdescribed in connection with FIGS. 30-32, according to one aspect of thepresent disclosure.

FIG. 34 is a schematic diagram of one aspect of a drive circuitconfigured for driving a high-frequency current (RF), according to oneaspect of the present disclosure.

FIG. 35 is a schematic diagram of the transformer coupled to the RFdrive circuit shown in FIG. 34, according to one aspect of the presentdisclosure.

FIG. 36 is a schematic diagram of a circuit comprising separate powersources for high power energy/drive circuits and low power circuits,according to one aspect of the resent disclosure.

FIG. 37 illustrates a control circuit that allows a dual generatorsystem to switch between the RF generator and the ultrasonic generatorenergy modalities for the surgical instrument shown in FIGS. 30 and 31.

FIG. 38 is a sectional view of an end effector, according to one aspectof the present disclosure.

FIG. 39 is a sectional view of an end effector, according to one aspectof the present disclosure.

FIG. 40 is a partial longitudinal sectional side view showing a distaljaw section in a closed state, according to one aspect of the presentdisclosure.

FIG. 41 is a partial longitudinal sectional side view showing the distaljaw section in an open state, according to one aspect of the presentdisclosure.

FIG. 42 is a partial longitudinal sectional side view showing a jawmember, according to one aspect of the present disclosure.

FIG. 43 is a cross-sectional view showing the distal jaw section in anormal state, according to one aspect of the present disclosure.

FIG. 44 is a cross-sectional view showing the distal jaw section in aworn state, according to one aspect of the present disclosure.

FIG. 45 illustrates a modular battery powered handheld electrosurgicalinstrument with distal articulation, according to one aspect of thepresent disclosure.

FIG. 46 is an exploded view of the surgical instrument shown in FIG. 45,according to one aspect of the present disclosure.

FIG. 47 is a perspective view of the surgical instrument shown in FIGS.45 and 46 with a display located on the handle assembly, according toone aspect of the present disclosure.

FIG. 48 is a perspective view of the instrument shown in FIGS. 45 and 46without a display located on the handle assembly, according to oneaspect of the present disclosure.

FIG. 49 is a motor assembly that can be used with the surgicalinstrument to drive the knife, according to one aspect of the presentdisclosure.

FIG. 50 is diagram of a motor drive circuit, according to one aspect ofthe present disclosure.

FIG. 51 illustrates a rotary drive mechanism to drive distal headrotation, articulation, and jaw closure, according to one aspect of thepresent disclosure.

FIG. 52 is an enlarged, left perspective view of an end effectorassembly with the jaw members shown in an open configuration, accordingto one aspect of the present disclosure.

FIG. 53 is an enlarged, right side view of the end effector assembly ofFIG. 52, according to one aspect of the present disclosure.

FIG. 54 illustrates a modular battery powered handheld electrosurgicalinstrument with distal articulation, according to one aspect of thepresent disclosure.

FIG. 55 is an exploded view of the surgical instrument shown in FIG. 54,according to one aspect of the present disclosure.

FIG. 56 is an enlarged area detail view of an articulation sectionillustrated in FIG. 54 including electrical connections, according toone aspect of the present disclosure.

FIG. 57 is an enlarged area detail view articulation section illustratedin FIG. 56 including electrical connections, according to one aspect ofthe present disclosure.

FIG. 58 illustrates a perspective view of components of the shaftassembly, end effector, and cutting member of the surgical instrument ofFIG. 54, according to one aspect of the present disclosure.

FIG. 59 illustrates the articulation section in a second stage ofarticulation, according to one aspect of the present disclosure.

FIG. 60 illustrates a perspective view of the end effector of the deviceof FIGS. 54-59 in an open configuration, according to one aspect of thepresent disclosure.

FIG. 61 illustrates a cross-sectional end view of the end effector ofFIG. 60 in a closed configuration and with the blade in a distalposition, according to one aspect to the present disclosure.

FIG. 62 illustrates the components of a control circuit of the surgicalinstrument, according to one aspect of the present disclosure.

FIG. 63 is a system diagram of a segmented circuit comprising aplurality of independently operated circuit segments, according to oneaspect of the present disclosure. FIG. 63 is a diagram of one form of adirect digital synthesis circuit.

FIG. 64 illustrates a diagram of one aspect of a surgical instrumentcomprising a feedback system for use with any one of the surgicalinstruments described herein in connection with FIGS. 1-61, which mayinclude or implement many of the features described herein

FIG. 65 illustrates one aspect of a fundamental architecture for adigital synthesis circuit such as a direct digital synthesis (DDS)circuit configured to generate a plurality of wave shapes for theelectrical signal waveform for use in any of the surgical instrumentsdescribed herein in connection with FIGS. 1-61, according to one aspectof the present disclosure.

FIG. 66 illustrates one aspect of direct digital synthesis (DDS) circuitconfigured to generate a plurality of wave shapes for the electricalsignal waveform for use in any of the surgical instruments describedherein in connection with FIGS. 1-61, according to one aspect of thepresent disclosure.

FIG. 67 illustrates one cycle of a discrete time digital electricalsignal waveform, according to one aspect of the present disclosure of ananalog waveform (shown superimposed over a discrete time digitalelectrical signal waveform for comparison purposes), according to oneaspect of the present disclosure.

FIG. 68A illustrates a circuit comprising a controller comprising one ormore processors coupled to at least one memory circuit for use in any ofthe surgical instruments described herein in connection with FIGS. 1-61,according to one aspect of the present disclosure.

FIG. 68B illustrates a circuit comprising a finite state machinecomprising a combinational logic circuit configured to implement any ofthe algorithms, processes, or techniques described herein, according toone aspect of the present disclosure.

FIG. 68C illustrates a circuit comprising a finite state machinecomprising a sequential logic circuit configured to implement any of thealgorithms, processes, or techniques described herein, according to oneaspect of the present disclosure.

FIG. 69 is a circuit diagram of various components of a surgicalinstrument with motor control functions, according to one aspect of thepresent disclosure.

FIG. 70 illustrates a handle assembly with a removable service panelremoved to shown internal components of the handle assembly, accordingto one aspect of the present disclosure.

FIG. 71 shows an example system of shaft control electronicsinterconnecting inside a portion of a handle assembly and shaft assemblyof a medical device, according to one aspect of the present disclosure.

FIG. 72 provides an example of a zoomed in portion of the flexiblecircuit, according to some aspects, according to one aspect of thepresent disclosure.

FIGS. 73A and 73B show how a plurality of sensors may be used incombination to measure and monitor movements of the medical device,according to one aspect of the present disclosure.

FIG. 74 provides another example of how multiple sensors can be used todetermine a three-dimensional position of one or more magnets, accordingto one aspect of the present disclosure.

FIG. 75 shows a variation of a shaft assembly of a medical device thatincludes a seal to protect sensitive electronics, according to oneaspect of the present disclosure.

DESCRIPTION

This application is related to following commonly owned patentapplications filed Dec. 16, 2016, the content of each of which isincorporated herein by reference in its entirety:

U.S. patent application Ser. No. 15/382,515, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT AND METHODS THEREFOR, by inventorsFrederick E. Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,274, now U.S. Pat. No.10,251,664, titled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENTWITH SELECTIVE APPLICATION OF ENERGY BASED ON TISSUE CHARACTERIZATION,by inventors Frederick E. Shelton, I V, et al., filed Dec. 16, 2016, nowIssued Apr. 9, 2019.

U.S. Patent Application Ser. No. 15/382,246 titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH SELECTIVE APPLICATION OFENERGY BASED ON BUTTON DISPLACEMENT, INTENSITY, OR LOCAL TISSUECHARACTERIZATION, by inventors Frederick E. Shelton, I V, et al., filedDec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,252, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH VARIABLE MOTOR CONTROL LIMITS,by inventors Frederick E. Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,257, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMIT PROFILE,by inventors Frederick E. Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,265, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMITS BASED ONTISSUE CHARACTERIZATION, by inventors Frederick E. Shelton, I V, et al.,filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,274, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH MULTI-FUNCTION MOTOR VIASHIFTING GEAR ASSEMBLY, by inventors Frederick E. Shelton, I V, et al.,filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,281, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH A PLURALITY OF CONTROLPROGRAMS, by inventor Frederick E. Shelton, IV, filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,283, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH ENERGY CONSERVATIONTECHNIQUES, by inventors Frederick E. Shelton, I V, et al., filed Dec.16, 2016.

U.S. Patent Application Ser. No. 15/382,285, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH VOLTAGE SAG RESISTANT BATTERYPACK, by inventors Frederick E. Shelton, I V, et al., filed Dec. 16,2016.

U.S. Patent Application Ser. No. 15/382,287, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH MULTISTAGE GENERATOR CIRCUITS,by inventors Frederick E. Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,290, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT CONTAINING ELONGATED MULTI-LAYEREDSHAFT, by inventors Frederick E. Shelton, I V, et al., filed Dec. 16,2016.

U.S. Patent Application Ser. No. 15/382,292, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR DRIVE, by inventorsFrederick E. Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,297, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH SELF-DIAGNOSING CONTROLSWITCHES FOR REUSABLE HANDLE ASSEMBLY, by inventors Frederick E.Shelton, I V, et al., filed Dec. 16, 2016.

U.S. Patent Application Ser. No. 15/382,306, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH REUSABLE ASYMMETRIC HANDLEHOUSING, by inventors Frederick E. Shelton, I V, et al., filed Dec. 16,2016.

U.S. Patent Application Ser. No. 15/382,309, titled MODULAR BATTERYPOWERED HANDHELD SURGICAL INSTRUMENT WITH CURVED END EFFECTORS HAVINGASYMMETRIC ENGAGEMENT BETWEEN JAW AND BLADE, by inventors Frederick E.Shelton, I V, et al., filed Dec. 16, 2016.

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols and reference characters typically identify similarcomponents throughout the several views, unless context dictatesotherwise. The illustrative aspects described in the detaileddescription, drawings, and claims are not meant to be limiting. Otheraspects may be utilized, and other changes may be made, withoutdeparting from the scope of the subject matter presented here.

Before explaining the various aspects of the present disclosure indetail, it should be noted that the various aspects disclosed herein arenot limited in their application or use to the details of constructionand arrangement of parts illustrated in the accompanying drawings anddescription. Rather, the disclosed aspects may be positioned orincorporated in other aspects, variations and modifications thereof, andmay be practiced or carried out in various ways. Accordingly, aspectsdisclosed herein are illustrative in nature and are not meant to limitthe scope or application thereof. Furthermore, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the aspects for the convenience of thereader and are not to limit the scope thereof. In addition, it should beunderstood that any one or more of the disclosed aspects, expressions ofaspects, and/or examples thereof, can be combined with any one or moreof the other disclosed aspects, expressions of aspects, and/or examplesthereof, without limitation.

Also, in the following description, it is to be understood that termssuch as front, back, inside, outside, top, bottom and the like are wordsof convenience and are not to be construed as limiting terms.Terminology used herein is not meant to be limiting insofar as devicesdescribed herein, or portions thereof, may be attached or utilized inother orientations. The various aspects will be described in more detailwith reference to the drawings.

In various aspects, the present disclosure is directed to a mixed energysurgical instrument that utilizes both ultrasonic and RF energymodalities. The mixed energy surgical instrument my use modular shaftsusing that accomplish existing end-effector functions such as ultrasonicfunctions disclosed in U.S. Pat. No. 9,107,690, which is incorporatedherein by reference in its entirety, combination device functionsdisclosed in U.S. Pat. Nos. 8,696,666 and 8,663,223, which are bothincorporated herein by reference in their entireties, RF opposedelectrode functions disclosed in U.S. Pat. Nos. 9,028,478 and 9,113,907,which are both incorporated herein by reference in their entireties, andRF I-blade offset electrode functions as disclosed in U.S. Pub. No.2013/0023868, which is incorporated herein by reference in its entirety.

In various aspects, the present disclosure is directed to a modularbattery powered handheld ultrasonic surgical instrument comprising afirst generator, a second generator, and a control circuit forcontrolling the energy modality applied by the surgical instrument. Thesurgical instrument is configured to apply at least one energy modalitythat comprises an ultrasonic energy modality, a radio frequency (RF)energy modality, or a combination ultrasonic and RF energy modalities.

In another aspect, the present disclosure is directed to a modularbattery powered handheld surgical instrument that can be configured forultrasonic energy modality, RF modality, or a combination of ultrasonicand RF energy modalities. A mixed energy surgical instrument utilizesboth ultrasonic and RF energy modalities. The mixed energy surgicalinstrument may use modular shafts that accomplish end effectorfunctions. The energy modality may be selectable based on a measure ofspecific measured tissue and device parameters, such as, for example,electrical impedance, tissue impedance, electric motor current, jaw gap,tissue thickness, tissue compression, tissue type, temperature, amongother parameters, or a combination thereof, to determine a suitableenergy modality algorithm to employ ultrasonic vibration and/orelectrosurgical high-frequency current to carry out surgicalcoagulation/cutting treatments on the living tissue based on themeasured tissue parameters identified by the surgical instrument. Oncethe tissue parameters have been identified, the surgical instrument maybe configured to control treatment energy applied to the tissue in asingle or segmented RF electrode configuration or in an ultrasonicdevice, through the measurement of specific tissue/device parameters.Tissue treatment algorithms are described in commonly owned U.S. patentapplication Ser. No. 15/177,430, titled SURGICAL INSTRUMENT WITH USERADAPTABLE TECHNIQUES, which is herein incorporated by reference in itsentirety.

In another aspect, the present disclosure is directed to a modularbattery powered handheld surgical instrument having a motor and acontroller, where a first limiting threshold is used on the motor forthe purpose of attaching a modular assembly and a second threshold isused on the motor and is associated with a second assembly step orfunctionality of the surgical instrument. The surgical instrument maycomprise a motor driven actuation mechanism utilizing control of motorspeed or torque through measurement of motor current or parametersrelated to motor current, wherein motor control is adjusted via anon-linear threshold to trigger motor adjustments at differentmagnitudes based on position, inertia, velocity, acceleration, or acombination thereof. Motor driven actuation of a moving mechanism and amotor controller may be employed to control the motor velocity ortorque. A sensor associated with physical properties of the movingmechanism provides feedback to the motor controller. In one aspect, thesensor is employed to adjust a predefined threshold which triggers achange in the operation of the motor controller. A motor may be utilizedto drive shaft functions such as shaft rotation and jaw closure andswitching that motor to also provide a torque limited waveguideattachment to a transducer. A motor control algorithm may be utilized togenerate tactile feedback to a user through a motor drive train forindication of device status and/or limits of the powered actuation. Amotor powered modular advanced energy based surgical instrument maycomprise a series of control programs or algorithms to operate a seriesof different shaft modules and transducers. In one aspect, the programsor algorithms reside in a module and are uploaded to a control handlewhen attached. The motor driven modular battery powered handheldsurgical instrument may comprise a primary rotary drive capable of beingselectably coupleable to at least two independent actuation functions(first, second, both, neither) and utilize a clutch mechanism located ina distal modular elongated tube.

In another aspect, the present disclosure is directed to modular batterypowered handheld surgical instrument comprising energy conservationcircuits and techniques using sleep mode de-energizing of a segmentedcircuit with short cuts to minimize non-use power drain and differingwake-up sequence order than the order of a sleep sequence. A disposableprimary cell battery pack may be utilized with a battery powered modularhandheld surgical instrument. The disposable primary cell may comprisepower management circuits to compensate the battery output voltage withadditional voltage to offset voltage sags under load and to prevent thebattery pack output voltage from sagging below a predetermined levelduring operation under load. The circuitry of the surgical instrumentcomprises radiation tolerant components and amplification of electricalsignals may be divided into multiple stages. An ultrasonic transducerhousing or RF housing may contain the final amplification stage and maycomprise different ratios depending on an energy modality associatedwith the ultrasonic transducer or RF module.

In another aspect, the present disclosure is directed to a modularbattery powered handheld surgical instrument comprising multiplemagnetic position sensors along a length of a shaft and paired indifferent configurations to allow multiple sensors to detect the samemagnet in order to determine three dimensional position of actuationcomponents of the shaft from a stationary reference plane andsimultaneously diagnosing any error from external sources. Control andsensing electronics may be incorporated in the shaft. A portion of theshaft control electronics may be disposed along the inside of movingshaft components and are separated from other shaft control electronicsthat are disposed along the outside of the moving shaft components.Control and sensing electronics may be situated and designed such thatthey act as a shaft seal in the device.

In another aspect, the present disclosure is directed to a modularbattery powered handheld surgical instrument comprising self diagnosingcontrol switches within a battery powered, modular, reusable handle. Thecontrol switches are capable of adjusting their thresholds fortriggering an event as well as being able to indicate externalinfluences on the controls or predict time till replacement needed. Thereusable handle housing is configured for use with modular disposableshafts and at least one control and wiring harness. The handle isconfigured to asymmetrically part when opened so that the switches,wiring harness, and/or control electronics can be supportably housed inone side such that the other side is removably attached to cover theprimary housing.

FIG. 1 is a diagram of a modular battery powered handheld ultrasonicsurgical instrument 100, according to an aspect of the presentdisclosure. FIG. 2 is an exploded view of the surgical instrument 100shown in FIG. 1, according to an aspect of the present disclosure. Withreference now to FIGS. 1 and 2, the surgical instrument 100 comprises ahandle assembly 102, an ultrasonic transducer/generator assembly 104, abattery assembly 106, a shaft assembly 110, and an end effector 112. Theultrasonic transducer/generator assembly 104, battery assembly 106, andshaft assembly 110 are modular components that are removably connectableto the handle assembly 102. The handle assembly 102 comprises a motorassembly 160. In addition, some aspects of the surgical instrument 100include battery assemblies 106 that contain the ultrasonic generator andmotor control circuits. The battery assembly 106 includes a first stagegenerator function with a final stage existing as part of the ultrasonictransducer/generator assembly 104 for driving 55 kHz and 33.1 kHzultrasonic transducers. A different final stage generator forinterchangeable use with the battery assembly 106, common generatorcomponents, and segmented circuits enable battery assembly 106 to powerup sections of the drive circuits in a controlled manner and to enablechecking of stages of the circuit before powering them up and enablingpower management modes. In addition, general purpose controls may beprovide in the handle assembly 102 with dedicated shaft assembly 110controls located on the shafts that have those functions. For instance,an end effector 112 module may comprise distal rotation electronics, theshaft assembly 110 may comprise rotary shaft control along witharticulation switches, and the handle assembly 102 may comprise energyactivation controls and jaw member 114 trigger 108 controls to clamp andunclamp the end effector 112.

The ultrasonic transducer/generator assembly 104 comprises a housing148, a display 176, such as a liquid crystal display (LCD), for example,an ultrasonic transducer 130, and an ultrasonic generator 162 (FIG. 4).The shaft assembly 110 comprises an outer tube 144 an ultrasonictransmission waveguide 145, and an inner tube (not shown). The endeffector 112 comprises a jaw member 114 and an ultrasonic blade 116. Asdescribed hereinbelow, a motor or other mechanism operated by thetrigger 108 may be employed to close the jaw member 114. The ultrasonicblade 116 is the distal end of the ultrasonic transmission waveguide145. The jaw member 114 is pivotally rotatable to grasp tissue betweenthe jaw member and the ultrasonic blade 116. The jaw member 114 isoperably coupled to a trigger 108 such that when the trigger 108 issqueezed the jaw member 114 closes to grasp tissue and when the trigger108 is released the jaw member 114 opens to release tissue. In aone-stage trigger configuration, the trigger 108 functions to close thejaw member 114 when the trigger 108 is squeezed and to open the jawmember 114 when the trigger 108 is released. Once the jaw member 114 isclosed, the switch 120 is activated to energize the ultrasonic generatorto seal and cut the tissue. In a two-stage trigger configuration, duringthe first stage, the trigger 108 is squeezed part of the way to closethe jaw member 114 and, during the second stage, the trigger 108 issqueezed the rest of the way to energize the ultrasonic generator toseal and cut the tissue. The jaw member 114 a opens by releasing thetrigger 108 to release the tissue. It will be appreciated that in otheraspects, the ultrasonic transducer 103 may be activated without the jawmember 114 being closed.

The battery assembly 106 is electrically connected to the handleassembly 102 by an electrical connector 132. The handle assembly 102 isprovided with a switch 120. The ultrasonic blade 116 is activated byenergizing the ultrasonic transducer/generator circuit by actuating theswitch 120. The battery assembly 106, according to one aspect, is arechargeable, reusable battery pack with regulated output. In somecases, as is explained below, the battery assembly 106 facilitatesuser-interface functions. The handle assembly 102 is a disposable unitthat has bays or docks for attachment to the battery assembly 106, theultrasonic transducer/generator assembly 104, and the shaft assembly110. The handle assembly 102 also houses various indicators including,for example, a speaker/buzzer and activation switches. In one aspect,the battery assembly is a separate component that is inserted into thehousing of the handle assembly through a door or other opening definedby the housing of the handle assembly.

The ultrasonic transducer/generator assembly 104 is a reusable unit thatproduces high frequency mechanical motion at a distal output. Theultrasonic transducer/generator assembly 104 is mechanically coupled tothe shaft assembly 110 and the ultrasonic blade 116 and, duringoperation of the device, produces movement at the distal output of theultrasonic blade 116. In one aspect, the ultrasonic transducer/generatorassembly 104 also provides a visual user interface, such as, through ared/green/blue (RGB) light-emitting diode (LED), LCD, or other display.As such, a visual indicator of the battery status is uniquely notlocated on the battery and is, therefore, remote from the battery.

In accordance with various aspects of the present disclosure, the threecomponents of the surgical instrument 100, e.g., the ultrasonictransducer/generator assembly 104, the battery assembly 106, and theshaft assembly 110, are advantageously quickly disconnectable from oneor more of the others. Each of the three components of the surgicalinstrument 100 is sterile and can be maintained wholly in a sterilefield during use. Because the components of the surgical instrument 100are separable, the surgical instrument 100 can be composed of one ormore portions that are single-use items (e.g., disposable) and othersthat are multi-use items (e.g., sterilizable for use in multiplesurgical procedures). Aspects of the components separate as part of thesurgical instrument 100. In accordance with an additional aspect of thepresent disclosure, the handle assembly 102, battery assembly 106, andshaft assembly 110 components is equivalent in overall weight; each ofthe handle assembly 102, battery assembly 106, and shaft assembly 110components is balanced so that they weigh the same or substantially thesame. The handle assembly 102 overhangs the operator's hand for support,allowing the user's hand to more freely operate the controls of thesurgical instrument 100 without bearing the weight. This overhang is setto be very close to the center of gravity. This combined with atriangular assembly configuration, makes the surgical instrument 100advantageously provided with a center of balance that provides a verynatural and comfortable feel to the user operating the device. That is,when held in the hand of the user, the surgical instrument 100 does nothave a tendency to tip forward or backward or side-to-side, but remainsrelatively and dynamically balanced so that the waveguide is heldparallel to the ground with very little effort from the user. Of course,the instrument can be placed in non-parallel angles to the ground justas easily.

A rotation knob 118 is operably coupled to the shaft assembly 110.Rotation of the rotation knob 118 ±360° in the direction indicated bythe arrows 126 causes an outer tube 144 to rotate ±360° in therespective direction of the arrows 128. In one aspect, the rotation knob118 may be configured to rotate the jaw member 114 while the ultrasonicblade 116 remains stationary and a separate shaft rotation knob may beprovided to rotate the outer tube 144 ±360°. In various aspects, theultrasonic blade 116 does not have to stop at ±360° and can rotate at anangle of rotation that is greater than ±360°. The outer tube 144 mayhave a diameter D₁ ranging from 5 mm to 10 mm, for example.

The ultrasonic blade 116 is coupled to an ultrasonic transducer 130(FIG. 2) portion of the ultrasonic transducer/generator assembly 104 byan ultrasonic transmission waveguide located within the shaft assembly110. The ultrasonic blade 116 and the ultrasonic transmission waveguidemay be formed as a unit construction from a material suitable fortransmission of ultrasonic energy. Examples of such materials includeTi6Al4V (an alloy of Titanium including Aluminum and Vanadium),Aluminum, Stainless Steel, or other suitable materials. Alternately, theultrasonic blade 116 may be separable (and of differing composition)from the ultrasonic transmission waveguide, and coupled by, for example,a stud, weld, glue, quick connect, or other suitable known methods. Thelength of the ultrasonic transmission waveguide may be an integralnumber of one-half wavelengths (nλ/2), for example. The ultrasonictransmission waveguide may be preferably fabricated from a solid coreshaft constructed out of material suitable to propagate ultrasonicenergy efficiently, such as the titanium alloy discussed above (i.e.,Ti6Al4V) or any suitable aluminum alloy, or other alloys, or othermaterials such as sapphire, for example.

The ultrasonic transducer/generator assembly 104 also compriseselectronic circuitry for driving the ultrasonic transducer 130. Theultrasonic blade 116 may be operated at a suitable vibrational frequencyrange may be about 20 Hz to 120 kHz and a well-suited vibrationalfrequency range may be about 30-100 kHz. A suitable operationalvibrational frequency may be approximately 55.5 kHz, for example. Theultrasonic transducer 130 is energized by the actuating the switch 120.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the handle assembly 102.Thus, the ultrasonic blade 116 is distal with respect to the handleassembly 102, which is more proximal. It will be further appreciatedthat, for convenience and clarity, spatial terms such as “top” and“bottom” also are used herein with respect to the clinician gripping thehandle assembly 102. However, surgical instruments are used in manyorientations and positions, and these terms are not intended to belimiting and absolute.

FIG. 3 is an exploded view of a modular shaft assembly 110 of thesurgical instrument 100 shown in FIG. 1, according to aspect of thepresent disclosure. The surgical instrument 100 uses ultrasonicvibration to carry out a surgical treatment on living tissue. The shaftassembly 110 couples to the handle assembly 102 via slots 142 a, 142 bformed on the handle assembly 102 and tabs 134 a, 134 b on the shaftassembly 110. The handle assembly 102 comprises a male coupling member136 that is received in a corresponding female coupling member in the138 shaft assembly 110. The male coupling member 136 is operably coupledto the trigger 108 such that when the trigger 108 is squeezed the malecoupling member 136 translates distally to drive a closure tubemechanism 140 that translates an outer tube portion of the shaftassembly 110 to close the jaw member 114. As previously discussed, whenthe trigger 108 is released, the jaw member 114 opens. The male couplingmember 136 also couples to the ultrasonic transmission waveguide 145(FIG. 2) located within the outer tube 144 of the shaft assembly 110 andcouples to the ultrasonic transducer 130 (FIG. 2), which is receivedwithin the nozzle 146 of the handle assembly 102. The shaft assembly 110is electrically coupled to the handle assembly 102 via electricalcontacts 137.

FIG. 4 is a perspective transparent view of the ultrasonictransducer/generator assembly 104 of the surgical instrument 100 shownin FIG. 1, according to aspect of the present disclosure. FIG. 5 is anend view of the ultrasonic transducer/generator assembly 104, FIG. 6 isa perspective view of the ultrasonic transducer/generator assembly 104with the top housing portion removed to expose the ultrasonic generator162, and FIG. 7 is a sectional view of the of the ultrasonictransducer/generator assembly 104. With reference now to FIGS. 4-7, theultrasonic transducer/generator assembly 104 comprises an ultrasonictransducer 130, an ultrasonic generator 162 to drive the ultrasonictransducer 130, and a housing 148. A first electrical connector 158couples the ultrasonic generator 162 to the battery assembly 106 (FIGS.1 and 2) and a second electrical connector 161 couples the ultrasonicgenerator 162 to the nozzle (FIG. 3). In one aspect, a display 176 maybe provided on one side of the ultrasonic transducer/generator assembly104 housing 148.

The ultrasonic generator 162 comprises an ultrasonic driver circuit suchas the electrical circuit 177 shown in FIG. 11 and, in some aspects, asecond stage amplifier circuit 178. The electrical circuit 177 isconfigured for driving the ultrasonic transducer 130 and forms a portionof the ultrasonic generator circuit. The electrical circuit 177comprises a transformer 166 and a blocking capacitor 168, among othercomponents. The transformer 166 is electrically coupled to thepiezoelectric elements 150 a, 150 b, 150 c, 150 d of the ultrasonictransducer 130. The electrical circuit 177 is electrically coupled tofirst electrical connector 158 via a first cable 179. The firstelectrical connector 158 is electrically coupled to the battery assembly106 (FIGS. 1 and 2). The electrical circuit 177 is electrically coupledto second electrical connector 160 via a second cable 183. The secondelectrical connector 160 is electrically coupled to the nozzle 146 (FIG.3). In one aspect, the second stage amplifier circuit 178 may beemployed in a two stage amplification system.

The ultrasonic transducer 130, which is known as a “Langevin stack”,generally includes a transduction portion comprising piezoelectricelements 150 a-150 d, a first resonator portion or end-bell 164, and asecond resonator portion or fore-bell 152, and ancillary components. Thetotal construction of these components is a resonator. There are otherforms of transducers, such as magnetostrictive transducers, that couldalso be used. The ultrasonic transducer 130 is preferably an integralnumber of one-half system wavelengths (nλ/2; where “n” is any positiveinteger; e.g., n=1, 2, 3 . . . ) in length as will be described in moredetail later. An acoustic assembly includes the end-bell 164, ultrasonictransducer 130, fore-bell 152, and a velocity transformer 154.

The distal end of the end-bell 164 is acoustically coupled to theproximal end of the piezoelectric element 150 a, and the proximal end ofthe fore-bell 152 is acoustically coupled to the distal end of thepiezoelectric element 150 d. The fore-bell 152 and the end-bell 164 havea length determined by a number of variables, including the thickness ofthe transduction portion, the density and modulus of elasticity of thematerial used to manufacture the end-bell 164 and the fore-bell 152, andthe resonant frequency of the ultrasonic transducer 130. The fore-bell152 may be tapered inwardly from its proximal end to its distal end toamplify the ultrasonic vibration amplitude at the velocity transformer154, or alternately may have no amplification. A suitable vibrationalfrequency range may be about 20 Hz to 120 kHz and a well-suitedvibrational frequency range may be about 30-100 kHz. A suitableoperational vibrational frequency may be approximately 55.5 kHz, forexample.

The ultrasonic transducer 130 comprises several piezoelectric elements150 a-150 d acoustically coupled or stacked to form the transductionportion. The piezoelectric elements 150 a-150 d may be fabricated fromany suitable material, such as, for example, lead zirconate-titanate,lead meta-niobate, lead titanate, barium titanate, or otherpiezoelectric ceramic material. Electrically conductive elements 170 a,170 b, 170 c, 170 d are inserted between the piezoelectric elements 150a-150 d to electrically couple the electrical circuit 177 to thepiezoelectric elements 150 a-150 d. The electrically conductive element170 a located between piezoelectric elements 150 a, 150 b and theelectrically conductive element 170 d located between piezoelectricelement 150 d and the fore-bell 152 are electrically coupled to thepositive electrode 174 a of the electrical circuit 177. The electricallyconductive element 170 b located between piezoelectric elements 150 b,150 c and the electrically conductive element 170 c located betweenpiezoelectric elements 150 c, 150 d are electrically coupled to thenegative electrode 174 b of the electrical circuit 177. The positive andnegative electrodes 174 a, 174 b are electrically coupled to theelectrical circuit 177 by electrical conductors.

The ultrasonic transducer 130 converts the electrical drive signal fromthe electrical circuit 177 into mechanical energy that results inprimarily a standing acoustic wave of longitudinal vibratory motion ofthe ultrasonic transducer 130 and the ultrasonic blade 116 (FIGS. 1 and3) at ultrasonic frequencies. In another aspect, the vibratory motion ofthe ultrasonic transducer 130 may act in a different direction. Forexample, the vibratory motion may comprise a local longitudinalcomponent of a more complicated motion of the ultrasonic blade 116. Whenthe acoustic assembly is energized, a vibratory motion in the form of astanding wave is generated through the ultrasonic transducer 130 to theultrasonic blade 116 at a resonance and amplitude determined by variouselectrical and geometrical parameters. The amplitude of the vibratorymotion at any point along the acoustic assembly depends upon thelocation along the acoustic assembly at which the vibratory motion ismeasured. A minimum or zero crossing in the vibratory motion standingwave is generally referred to as a node (i.e., where motion is minimal),and a local absolute value maximum or peak in the standing wave isgenerally referred to as an anti-node (i.e., where local motion ismaximal). The distance between an anti-node and its nearest node isone-quarter wavelength (λ/4).

The wires transmit an electrical drive signal from the electricalcircuit 177 to the positive electrode 170 a and the negative electrode170 b. The piezoelectric elements 150 a-150 d are energized by theelectrical signal supplied from the electrical circuit 177 in responseto an actuator, such as the switch 120, for example, to produce anacoustic standing wave in the acoustic assembly. The electrical signalcauses disturbances in the piezoelectric elements 150 a-150 d in theform of repeated small displacements resulting in large alternatingcompression and tension forces within the material. The repeated smalldisplacements cause the piezoelectric elements 150 a-150 d to expand andcontract in a continuous manner along the axis of the voltage gradient,producing longitudinal waves of ultrasonic energy. The ultrasonic energyis transmitted through the acoustic assembly to the ultrasonic blade 116(FIGS. 1 and 3) via a transmission component or an ultrasonictransmission waveguide through the shaft assembly 110 (FIGS. 1-3).

In order for the acoustic assembly to deliver energy to the ultrasonicblade 116 (FIGS. 1 and 3), components of the acoustic assembly areacoustically coupled to the ultrasonic blade 116. A coupling stud 156 ofthe ultrasonic transducer 130 is acoustically coupled to the ultrasonictransmission waveguide 145 by a threaded connection such as a stud. Inone aspect, the ultrasonic transducer 130 may be acoustically coupled tothe ultrasonic transmission waveguide 145 as shown in FIGS. 10A and 10B.

The components of the acoustic assembly are preferably acousticallytuned such that the length of any assembly is an integral number ofone-half wavelengths (nλ/2), where the wavelength λ is the wavelength ofa pre-selected or operating longitudinal vibration drive frequency f_(d)of the acoustic assembly. It is also contemplated that the acousticassembly may incorporate any suitable arrangement of acoustic elements.

The ultrasonic blade 116 (FIGS. 1 and 3) may have a length that is anintegral multiple of one-half system wavelengths (nλ/2). A distal end ofthe ultrasonic blade 116 may be disposed near an antinode in order toprovide the maximum longitudinal excursion of the distal end. When theultrasonic transducer 130 is energized, the distal end of the ultrasonicblade 116 may be configured to move in the range of, for example,approximately 10 to 500 microns peak-to-peak, and preferably in therange of about 30 to 150 microns, and in some aspects closer to 100microns, at a predetermined vibrational frequency of 55 kHz, forexample.

FIG. 8 is an elevation view of an ultrasonic transducer/generatorassembly 104 that is configured to operate at 31 kHz resonant frequency,according to one aspect of the present disclosure. FIG. 9 is anelevation view of an ultrasonic transducer/generator assembly 104′ thatis configured to operate at 55 kHz resonant frequency, according to oneaspect of the present disclosure. As can be seen, the ultrasonictransducer/generator assemblies 104, 104′, the housings 148 are the samesize in order to fit into the nozzle 146 of the surgical instrument 100shown in FIG. 3. Nevertheless, the individual ultrasonic transducers130, 130′ will vary in size depending on the desired resonant frequency.For example, the ultrasonic transducer 130 shown in FIG. 8 is tuned at aresonant frequency of 31 kHz is physically larger than the ultrasonictransducer 130′ shown in FIG. 9, which is tuned at a resonant frequencyof 55 kHz. The coupling stud 156, 156′ of the ultrasonic transducer 130,130′ may be acoustically coupled to the ultrasonic transmissionwaveguide 145 by a threaded connection such as a stud.

FIGS. 10A and 10B illustrate a shifting assembly 200 that selectivelyrotates the ultrasonic transmission waveguide 145 with respect to theultrasonic transducer 130 and urges them towards one another, accordingto one aspect of the present disclosure. FIG. 10A illustrates theshifting assembly 200 with the ultrasonic transmission waveguide 145 andthe ultrasonic transducer 130 in a disengaged configuration and FIG. 10Billustrates the shifting assembly 200 with the ultrasonic transmissionwaveguide 145 and the ultrasonic transducer 130 in an engagedconfiguration. With reference now to both FIGS. 10A and 10B, theshifting assembly 200 is located in the handle assembly 102 of thesurgical instrument 100. One or more sleeves 204 hold the ultrasonictransducer 130 in place within the housing 148. The distal end of theultrasonic transducer 130 includes threads 202 that are engaged by aworm gear 206. As the worm gear 206 rotates the ultrasonic transducer130 is urged in the direction indicated by the arrow 208 to thread thethreaded coupling stud 156 into a threaded end of the ultrasonictransmission waveguide 145. The worm gear 206 may be driven by a motorlocated within the handle assembly 102 of the surgical instrument 100.

In one aspect, the shifting assembly 200 may include a torque limitedmotor driven attachment of the ultrasonic transmission waveguide 145 viathe motor located in the handle assembly 102 that controls shaftactuation of clamping, rotation, and articulation. The shifting assembly200 in the handle assembly 102 applies the proper torque onto theultrasonic transmission waveguide 145 into place with a predeterminedminimum torque. For instance, the handle assembly 102 may include atransducer torqueing mechanism which shifts the primary motorlongitudinally uncoupling the primary drive shaft spur gear and couplingthe transducer torqueing gear which rotates the shaft and nozzletherefore screwing the wave guide into the transducer.

FIG. 11 is a schematic diagram of one aspect of a electrical circuit 177shown in FIG. 4, suitable for driving an ultrasonic transducer 130,according to one aspect of the present disclosure. The electricalcircuit 177 comprises an analog multiplexer 180. The analog multiplexer180 multiplexes various signals from the upstream channels SCL-A/SDA-Asuch as ultrasonic, battery, and power control circuit. A current sensor182 is coupled in series with the return or ground leg of the powersupply circuit to measure the current supplied by the power supply. Afield effect transistor (FET) temperature sensor 184 provides theambient temperature. A pulse width modulation (PWM) watchdog timer 188automatically generates a system reset if the main program neglects toperiodically service it. It is provided to automatically reset theelectrical circuit 177 when it hangs or freezes because of a software orhardware fault. It will be appreciated that the electrical circuit 177may be configured as an RF driver circuit for driving the ultrasonictransducer 130 or for driving RF electrodes such as the electricalcircuit 702 shown in FIG. 34, for example. Accordingly, with referencenow back to FIG. 11, the electrical circuit 177 can be used to driveboth ultrasonic transducers and RF electrodes interchangeably. If drivensimultaneously, filter circuits may be provided in the correspondingfirst stage circuits 5504 to select either the ultrasonic waveform orthe RF waveform. Such filtering techniques are described in commonlyowned U.S. patent application Ser. No. 15/265,293, titled TECHNIQUES FORCIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is herein incorporatedby reference in its entirety.

A drive circuit 186 provides left and right ultrasonic energy outputs. Adigital signal the represents the signal waveform is provided to theSCL-A/SDA-A inputs of the analog multiplexer 180 from a control circuit,such as the control circuit 210 (FIG. 14). A digital-to-analog converter190 (DAC) converts the digital input to an analog output to drive a PWMcircuit 192 coupled to an oscillator 194. The PWM circuit 192 provides afirst signal to a first gate drive circuit 196 a coupled to a firsttransistor output stage 198 a to drive a first ultrasonic (Left) energyoutput. The PWM circuit 192 also provides a second signal to a secondgate drive circuit 196 b coupled to a second transistor output stage 198b to drive a second ultrasonic (Right) energy output. A voltage sensor199 is coupled between the Ultrasonic Left/Right output terminals tomeasure the output voltage. The drive circuit 186, the first and seconddrive circuits 196 a, 196 b, and the first and second transistor outputstages 198 a, 198 b define a first stage amplifier circuit. Inoperation, the control circuit 210 (FIG. 14) generates a digitalwaveform 1800 (FIG. 67) employing circuits such as direct digitalsynthesis (DDS) circuits 1500, 1600 (FIGS. 65 and 66). The DAC 190receives the digital waveform 1800 and converts it into an analogwaveform, which is received and amplified by the first stage amplifiercircuit.

FIG. 12 is a schematic diagram of the transformer 166 coupled to theelectrical circuit 177 shown in FIG. 11, according to one aspect of thepresent disclosure. The Ultrasonic Left/Right input terminals (primarywinding) of the transformer 166 are electrically coupled to theUltrasonic Left/Right output terminals of the electrical circuit 177.The secondary winding of the transformer 166 are coupled to the positiveand negative electrodes 174 a, 174 b. The positive and negativeelectrodes 174 a, 174 b of the transformer 166 are coupled to thepositive terminal 170 a (Stack 1) and the negative terminal 170 b (Stack2) of the ultrasonic transducer 130 (FIG. 4). In one aspect, thetransformer 166 has a turns-ratio of n1:n2 of 1:50.

FIG. 13 is a schematic diagram of the transformer 166 shown in FIG. 12coupled to a test circuit 165, according to one aspect of the presentdisclosure. The test circuit 165 is coupled to the positive and negativeelectrodes 174 a, 174 b. A switch 167 is placed in series with aninductor/capacitor/resistor (LCR) load that simulates the load of anultrasonic transducer.

FIG. 14 is a schematic diagram of a control circuit 210, according toone aspect of the present disclosure. The control circuit 210 is locatedwithin a housing of the battery assembly 106. The battery assembly 106is the energy source for a variety of local power supplies 215. Thecontrol circuit comprises a main processor 214 coupled via an interfacemaster 218 to various downstream circuits by way of outputs SCL-A/SDA-A,SCL-B/SDA-B, SCL-C/SDA-C, for example. In one aspect, the interfacemaster 218 is a general purpose serial interface such as an I²C serialinterface. The main processor 214 also is configured to drive switches224 through general purposes input output 220 (GPIO), a display 226(e.g., and LCD display), and various indicators 228 trough GPIO 222. Awatchdog processor 216 is provided to control the main processor 214. Aswitch 230 is provided in series with the battery 211 to activate thecontrol circuit 212 upon insertion of the battery assembly 106 into thehandle assembly 102 (FIGS. 1-3).

In one aspect, the main processor 214 is coupled to the electricalcircuit 177 (FIGS. 4 and 11) by way of output terminals SCL-A/SDA-A. Themain processor 214 comprises a memory for storing tables of digitizeddrive signals or waveforms that are transmitted to the electricalcircuit 177 for driving the ultrasonic transducer 130 (FIGS. 4-8), forexample. In other aspects, the main processor 214 may generate a digitalwaveform and transmit it to the electrical circuit 177 or may store thedigital waveform for later transmission to the electrical circuit 177.The main processor 214 also may provide RF drive by way of outputterminals SCL-B/SDA-B and various sensors (e.g., Hall-effect sensors,magnetorheological fluid (MRF) sensors, etc.) by way of output terminalsSCL-C/SDA-C. In one aspect, the main processor 214 is configured tosense the presence of ultrasonic drive circuitry and/or RF drivecircuitry to enable appropriate software and user interfacefunctionality.

In one aspect, the main processor 214 may be an LM 4F230H5QR, availablefrom Texas Instruments, for example. In at least one example, the TexasInstruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprisingon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QED analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available for the productdatasheet. Other processors may be readily substituted and, accordingly,the present disclosure should not be limited in this context.

FIG. 15 shows a simplified block circuit diagram illustrating anotherelectrical circuit 300 contained within a modular ultrasonic surgicalinstrument 334, according to one aspect of the present disclosure. Theelectrical circuit 300 includes a processor 302, a clock 330, a memory326, a power supply 304 (e.g., a battery), a switch 306, such as ametal-oxide semiconductor field effect transistor (MOSFET) power switch,a drive circuit 308 (PLL), a transformer 310, a signal smoothing circuit312 (also referred to as a matching circuit and can be, e.g., a tankcircuit), a sensing circuit 314, a transducer 130, and a shaft assembly110 comprising an ultrasonic transmission waveguide that terminates atan ultrasonic blade 116, which may be referred to herein simply as thewaveguide.

One feature of the present disclosure that severs dependency on highvoltage (120 VAC) input power (a characteristic of general ultrasoniccutting devices) is the utilization of low-voltage switching throughoutthe wave-forming process and the amplification of the driving signalonly directly before the transformer stage. For this reason, in oneaspect of the present disclosure, power is derived from only a battery,or a group of batteries, small enough to fit either within the handleassembly 102 (FIGS. 1-3). State-of-the-art battery technology providespowerful batteries of a few centimeters in height and width and a fewmillimeters in depth. By combining the features of the presentdisclosure to provide a self-contained and self-powered ultrasonicdevice, a reduction in manufacturing cost may be achieved.

The output of the power supply 304 is fed to and powers the processor302. The processor 302 receives and outputs signals and, as will bedescribed below, functions according to custom logic or in accordancewith computer programs that are executed by the processor 302. Theelectrical circuit 300 can also include a memory 326, preferably, randomaccess memory (RAM), that stores computer-readable instructions anddata.

The output of the power supply 304 also is directed to a switch 306having a duty cycle controlled by the processor 302. By controlling theon-time for the switch 306, the processor 302 is able to dictate thetotal amount of power that is ultimately delivered to the transducer316. In one aspect, the switch 306 is a MOSFET, although other switchesand switching configurations are adaptable as well. The output of theswitch 306 is fed to a drive circuit 308 that contains, for example, aphase detecting phase-locked loop (PLL) and/or a low-pass filter and/ora voltage-controlled oscillator. The output of the switch 306 is sampledby the processor 302 to determine the voltage and current of the outputsignal (V IN and I IN, respectively). These values are used in afeedback architecture to adjust the pulse width modulation of the switch306. For instance, the duty cycle of the switch 306 can vary from about20% to about 80%, depending on the desired and actual output from theswitch 306.

The drive circuit 308, which receives the signal from the switch 306,includes an oscillatory circuit that turns the output of the switch 306into an electrical signal having an ultrasonic frequency, e.g., 55 kHz(VCO). As explained above, a smoothed-out version of this ultrasonicwaveform is ultimately fed to the ultrasonic transducer 130 to produce aresonant sine wave along the ultrasonic transmission waveguide 145 (FIG.2).

At the output of the drive circuit 308 is a transformer 310 that is ableto step up the low voltage signal(s) to a higher voltage. It is notedthat upstream switching, prior to the transformer 310, is performed atlow (e.g., battery driven) voltages, something that, to date, has notbeen possible for ultrasonic cutting and cautery devices. This is atleast partially due to the fact that the device advantageously uses lowon-resistance MOSFET switching devices. Low on-resistance MOSFETswitches are advantageous, as they produce lower switching losses andless heat than a traditional MOSFET device and allow higher current topass through. Therefore, the switching stage (pre-transformer) can becharacterized as low voltage/high current. To ensure the loweron-resistance of the amplifier MOSFET(s), the MOSFET(s) are run, forexample, at 10 V. In such a case, a separate 10 VDC power supply can beused to feed the MOSFET gate, which ensures that the MOSFET is fully onand a reasonably low on resistance is achieved. In one aspect of thepresent disclosure, the transformer 310 steps up the battery voltage to120V root-mean-square (RMS). Transformers are known in the art and are,therefore, not explained here in detail.

In the circuit configurations described, circuit component degradationcan negatively impact the circuit performance of the circuit. One factorthat directly affects component performance is heat. Known circuitsgenerally monitor switching temperatures (e.g., MOSFET temperatures).However, because of the technological advancements in MOSFET designs,and the corresponding reduction in size, MOSFET temperatures are nolonger a valid indicator of circuit loads and heat. For this reason,according to one aspect of the present disclosure, a sensing circuit 314senses the temperature of the transformer 310. This temperature sensingis advantageous as the transformer 310 is run at or very close to itsmaximum temperature during use of the device. Additional temperaturewill cause the core material, e.g., the ferrite, to break down andpermanent damage can occur. The present disclosure can respond to amaximum temperature of the transformer 310 by, for example, reducing thedriving power in the transformer 310, signaling the user, turning thepower off, pulsing the power, or other appropriate responses.

In one aspect of the present disclosure, the processor 302 iscommunicatively coupled to the end effector 112, which is used to placematerial in physical contact with the ultrasonic blade 116, e.g., theclamping mechanism shown in FIG. 1. Sensors are provided that measure,at the end effector 112, a clamping force value (existing within a knownrange) and, based upon the received clamping force value, the processor302 varies the motional voltage VM. Because high force values combinedwith a set motional rate can result in high blade temperatures, atemperature sensor 336 can be communicatively coupled to the processor302, where the processor 302 is operable to receive and interpret asignal indicating a current temperature of the blade from thetemperature sensor 336 and to determine a target frequency of blademovement based upon the received temperature. In another aspect, forcesensors such as strain gages or pressure sensors may be coupled to thetrigger 108 to measure the force applied to the trigger 108 by the user.In another aspect, force sensors such as strain gages or pressuresensors may be coupled to the switch 120 button such that displacementintensity corresponds to the force applied by the user to the switch 120button.

According to one aspect of the present disclosure, the PLL portion ofthe drive circuit 308, which is coupled to the processor 302, is able todetermine a frequency of waveguide movement and communicate thatfrequency to the processor 302. The processor 302 stores this frequencyvalue in the memory 326 when the device is turned off. By reading theclock 330, the processor 302 is able to determine an elapsed time afterthe device is shut off and retrieve the last frequency of waveguidemovement if the elapsed time is less than a predetermined value. Thedevice can then start up at the last frequency, which, presumably, isthe optimum frequency for the current load.

FIG. 16 shows a battery assembly 400 for use with the surgicalinstrument 100, according to one aspect of the present disclosure. Thebattery assembly 400 comprises a housing 402 sized and configured tocontain various energy cells. The energy cells may include rechargeableand non-rechargeable batteries. In one aspect, the battery assembly 400includes four Li-ion non-rechargeable batteries 404 a, 404 b, 404 c, 404d and two nickel metal hydride (NiMH) rechargeable batteries 406 a (thesecond battery is not shown). The housing 402 comprises tabs 408 a, 408b to removably connect the battery assembly 400 to the handle assembly102 of the surgical instrument 100 (FIGS. 1 and 2).

FIG. 17 shows a disposable battery assembly 410 for use with thesurgical instrument 100, according to one aspect of the presentdisclosure. In one aspect, the disposable battery assembly 410 comprisesa primary cell battery pack for use with a battery powered advancedenergy instrument such as the surgical instrument 100 (FIGS. 1 and 2),comprising compensating electronics with additional voltage to offset avoltage sag from the disposable battery assembly 410 to prevent theoutput voltage from sagging below a predetermined level during operationunder load. The disposable battery assembly 410 comprises a housing 412sized and configured to contain various energy cells. The energy cellsmay include rechargeable and non-rechargeable batteries. In one aspect,the disposable battery assembly 410 includes four primary Lithium-ion(Li-ion) non-rechargeable batteries 414 a, 414 b, 414 c, 414 d and twosecondary NiMH or Nickel Cadmium (NiCd) rechargeable batteries 416 a,416 b. The housing 412 comprises electrical contact 418 to electricallycouple the disposable battery assembly 410 to the handle assembly 102 ofthe surgical instrument 100. In the illustrated example the electricalcontact 418 comprises four metal contacts. The disposable batteryassembly 410 also includes electrical circuits 419 such as the controlcircuit 210 (FIG. 14) and/or the electrical circuit 300 (FIG. 15). Theelectrical circuits 419 are radiated hardened.

In one aspect, the disposable battery assembly 410 includes batteries414 a-d, electrical circuits 419, and other componentry that isresistant to gamma or other radiation sterilization. For instance, aswitching mode power supply 460 (FIG. 22) or a linear power supply 470(FIG. 24) and an optional charge circuit may be incorporated within thehousing 412 of the disposable battery assembly 410 to reduce voltage sagof the primary Li-ion batteries 414 a-d and to allow the secondary NiMHbatteries 416 a, 416 b to be used to reduce voltage sag. This guaranteesfull charged cells at the beginning of each surgery that are easy tointroduce into the sterile field. A dual type battery assembly includingprimary Li-ion batteries 414 a-d and secondary NiMH batteries 416 a-bcan be used with dedicated energy cells 416 a-b to control theelectronics from dedicated energy cells 414 a-d that run the generatorand motor control circuits. In one aspect, the system pulls from thebatteries involved in driving the electronics circuits in the case thatbatteries involved are dropping low. In one aspect, the system wouldinclude a one way diode system that would not allow for current to flowin the opposite direction, for example, from the batteries involved indriving the energy and/or motor control circuits to the batteriesinvolved in driving the electronic circuits. In one additional aspect,the system may comprise a gamma friendly charge circuit and switch modepower supply using diodes and vacuum tube components that would minimizevoltage sag at a predetermined level. The switch mode power supply maybe eliminated by including a minimum sag voltage that is a division ofthe NiMH voltages (e.g., three NiMH cells). In another aspect, a modularsystem can be made wherein the radiation hardened components are locatedin a module, making this module sterilizable by radiation sterilization.Other non-radiation hardened components are included in other modularcomponents and connections are made between the modular components suchthat the componentry operate together as if the components were locatedtogether on the same circuit board. If only two cells of the secondaryNiMH batteries 416 a-b are desired the switch mode power supply based ondiodes and vacuum tubes allows for sterilizable electronics within thedisposable primary Li-ion batteries 414 a-d.

FIG. 18 shows a reusable battery assembly 420 for use with the surgicalinstrument 100, according to one aspect of the present disclosure. Thereusable battery assembly 420 comprises a housing 422 sized andconfigured to contain various rechargeable energy cells. The energycells may include rechargeable batteries. In one aspect, the reusablebattery assembly 420 includes five laminated NiMH rechargeable batteries424 a, 424 b, 424 c, 424 d, 424 e. The housing 422 comprises electricalcontact 428 to electrically couple the reusable battery assembly 420 tothe handle assembly 102 of the surgical instrument 100 (FIGS. 1 and 2).In the illustrated example, the electrical contact 428 comprises sixmetal contacts. The reusable battery assembly 420 also includes up tosix circuit boards 429 a, 429 b, 429 c, 429 d, 429 e, 429 f that mayinclude electrical circuits such as the control circuit 210 (FIG. 14)and/or the electrical circuit 300 (FIG. 15). In one aspect, the reusablebattery assembly 420 comprises drive FET transistors and associatedcircuitry 429 a-f in the housing 422 for easy swap and no need to shutdown the surgical instrument 100 (FIGS. 1 and 2) to replace the reusablebattery assembly 420 with energy delivery.

The reusable battery assembly 420 comprises a battery test switch 426and up to three LED indicators 427 a, 427 b, 427 c to determine thehealth of the batteries 424 a-e in the reusable battery assembly 420.The first LED indicator 427 a may indicate fully charged batteries 424a-e that is ready to use. The second LED indicator 427 b may indicatethat the battery needs to be recharged. The third LED indicator 427 cmay indicate that battery is not good and to dispose. The reusablebattery assembly 420 health indication to allow the user to determinethe specific health and capabilities of the batteries 424 a-e before itis inserted and used. For instance, charge status of the rechargeablesecondary cells, sag voltage, primary cell voltage are checked by theactivation of the battery test switch 426 which could measure these inan unload state or with a predefined resistive load placed on thesystem. The voltages could have at least one but more preferably threethresholds to compare the resulting voltages checks to. In the case ofthe first indicator 427 a, the batteries 424 a-e indicating whether ornot they are suitable to use. With three levels the reusable batteryassembly 420 could display full charge, minimum charge, and somemarginal but limited charge status. This battery 424 a-e health monitorwould be useful for either the disposable battery assembly 410 (FIG. 17)or the reusable battery assembly 420. In the case of the disposablebattery assembly 410 it is a ready/damaged indicator. In the case of thereusable battery assembly 420 it could indicate life remaining, rechargecapacity, even age before failure in addition to ready/not ready.

FIG. 19 is an elevated perspective view of a removable battery assembly430 with both halves of the housing shell removed exposing battery cellscoupled to multiple circuit boards which are coupled to the multi-leadbattery terminal in accordance with an aspect of the present disclosure.Further, more than or less than three circuit boards is possible toprovide expanded or limited functionality. As shown in FIG. 19, themultiple circuit boards 432, 434, 436 may be positioned in a stackedarchitecture, which provides a number of advantages. For example, due tothe smaller layout size, the circuit boards have a reduced footprintwithin the removable battery assembly 430, thereby allowing for asmaller battery. In addition, in this configuration, is possible toeasily isolate power boards from digital boards to prevent any noiseoriginating from the power boards to cause harm to the digital boards.Also, the stacked configuration allows for direct connect featuresbetween the boards, thereby reducing the presence of wires. Furthermore,the circuit boards can be configured as part of a rigid-flex-rigidcircuit to allow the rigid parts to be “fanned” into a smallervolumetric area.

According to aspects of the present disclosure, the circuit board 432,434, 436 provides a specific function. For instance, one circuit board432 can provide the components for carrying out the battery protectioncircuitry. Similarly, another circuit board 434 can provide thecomponents for carrying out the battery controller. Another circuitboard 436 can, for example, provide high power buck controllercomponents. Finally, the battery protection circuitry can provideconnection paths for coupling the battery cells 438 a-n. By placing thecircuit boards in a stacked configuration and separating the boards bytheir respective functions, the boards may be strategically placed in aspecific order that best handles their individual noise and heatgeneration. For example, the circuit board having the high-power buckcontroller components produces the most heat and, therefore, it can beisolated from the other boards and placed in the center of the stack. Inthis way, the heat can be kept away from the outer surface of the devicein an effort to prevent the heat from being felt by the physician oroperator of the device. In addition, the battery board grounds may beconfigured in a star topology with the center located at the buckcontroller board to reduce the noise created by ground loops.

The strategically stacked circuit boards, the low thermal conductivitypath from the circuit boards to the multi-lead battery terminalassembly, and a flex circuit 3516 are features that assist in preventingheat from reaching the exterior surface of the device. The battery cellsand buck components are thermally connected to a flex circuit within thehandle assembly 102 (FIGS. 1 and 2) so that the heat generated by thecells and buck components enter a portion away from the physician'shand. The flex circuit presents a relatively high thermal mass, due toits broad area of exposure and the advantageous conductioncharacteristics of the copper, which redirects, absorbs, and/ordissipates heat across a broader area thereby slowing the concentrationof heat and limiting high spot temperatures on the exterior surface ofthe device. Other techniques may be implemented as well, including, butnot limited to, larger heat wells, sinks or insulators, a metalconnector cap and heavier copper content in the flex circuit or thehandle assembly 102 of the device.

Another advantage of the removable battery assembly 430 is realized whenLi-ion batteries are used. As previously stated, Li-ion batteries shouldnot be charged in a parallel configuration of multiple cells. This isbecause, as the voltage increases in a particular cell, it begins toaccept additional charge faster than the other lower-voltage cells.Therefore, the cells are monitored so that a charge to that cell can becontrolled individually. When a Li-ion battery is formed from a group ofcells 438 a-n, a multitude of wires extending from the exterior of thedevice to the batteries 438 a-n is needed (at least one additional wirefor each battery cell beyond the first). By having a removable batteryassembly 430, a battery cell 438 a-n can, in one aspect, have its ownexposed set of contacts and, when the removable battery assembly 430 isnot present inside the handle assembly 102 (FIGS. 1 and 2), a set ofcontacts can be coupled to a corresponding set of contacts in anexternal, non-sterile, battery-charging device. In another aspect, abattery cell 438 a-n can be electrically connected to the batteryprotection circuitry to allow the battery protection circuitry tocontrol and regulate recharging of a cell 438 a-n. The removable batteryassembly 430 is provided with circuitry to prevent use of the removablebattery assembly 430 past an expected term-of-life. This term is notonly dictated by the cells but is also dictated by the outer surfaces,including the battery casing or shell and the upper contact assembly.Such circuitry will be explained in further detail below and includes,for example, a use count, a recharge count, and an absolute time frommanufacture count.

FIG. 19 also shows a multi-lead battery terminal assembly 433, which isan interface that electrically couples the components within theremovable battery assembly 430 to an electrical interface of the handleassembly 102 (FIGS. 1 and 2). It is through the handle assembly 102 thatthe removable battery assembly 430 is able to electrically (andmechanically) couple with the ultrasonic transducer/generator assembly104 (FIG. 4). As is explained above, the removable battery assembly 430,through the multi-lead battery terminal assembly 433, provides power tothe surgical instrument 100 (FIGS. 1 and 2), as well as otherfunctionality described herein. The multi-lead battery terminal assembly433 includes a plurality of contacts pads 435 a-n capable of separatelyelectrically connecting a terminal within the removable battery assembly430 to another terminal provided by a docking bay of the handle assembly102. One example of such electrical connections coupled to the pluralityof contact pads 435 a-n as power and communication signal paths. In theaspect of the multi-lead battery terminal assembly 433, sixteendifferent contact pads 435 a-n are shown. This number is merelyillustrative. In an aspect, an interior side of the battery terminalassembly 433 has a well formed on the molded terminal holder that can befilled with potting materials to create a gas tight seal. The contactpads 435 a-n are overmolded in the lid and extend through the pottingwell into the interior of the battery 430. Here a flex circuit can beused to rearrange the array of pins and provide an electrical connectionto the circuit boards. In one example, a 4×4 array is converted to a 2×8array. In one example the multi-lead battery terminal assembly 433, aplurality of contact pads 435 a-n of the multi-lead battery terminalassembly 2804 include a corresponding plurality of interior contact pins437 a-n. A contact pin 437 a provides a direct electrical coupling to acorresponding one of the contact pads 435 a.

FIG. 20 illustrates a battery test circuit 440, according to one aspectof the present disclosure. The battery test circuit 440 includes thebattery test switch 426 as described in FIG. 18. The battery test switch426 is a switch that engages an LCR dummy load that simulates atransducer or shaft assembly electronics. As described in FIG. 18,additional indicator circuits may be coupled to the battery test circuit440 to provide a suitable indication of the capacity of the batteries inthe reusable battery assembly 420. The illustrated battery test circuit440 may be employed in any of the battery assemblies 400, 410, 420, 430described in connection with FIGS. 16-19, respectively.

FIG. 21 illustrates a supplemental power source circuit 450 to maintaina minimum output voltage, according to one aspect of the presentdisclosure. The supplemental power source circuit 450 may be included inany of the battery assemblies 400, 410, 420, 430 described in connectionwith FIGS. 16-19. The supplemental power source circuit 450 prevents theoutput voltage V_(o) from sagging under high load conditions. Thesupplemental power source circuit 450 includes a set of four primarybatteries 452 a-b, 452 c-d (up to n batteries may be used) that areactivated when the switch 453 closes upon insertion of the batteryassembly 400, 410, 420, 430 into the handle assembly 102 of the surgicalinstrument 100 (FIGS. 1 and 2). The primary batteries 452 a-d may beLi-ion batteries such as CR123A Li-ion batteries. Under load, theprimary batteries 452 a-d provide the output voltage V_(o) while thesecondary rechargeable battery 454 is charged by the battery charger455. In one aspect, the secondary rechargeable battery 454 in a NiMHbattery and the battery charger 455 is a suitable NiMH charger. When theoutput voltage V_(o) sags or droops due to high load conditions thevoltage V_(x) operates the switch mode power supply 456 to restore theoutput voltage V_(o) by supplying the additional current into the load.The diode 458 is provided to prevent current from flowing into theoutput of the switch mode power supply 456. Accordingly, the outputvoltage V_(b) of the switch mode power supply 456 must exceed thevoltage drop across the diode 458 (˜0.7V) before the supplementalcurrent can flow into the load. Optionally, a battery test switch 459and test resistor R_(Test) may be provided to test the supplementalpower source circuit 450 under load conditions. In particular, in viewof FIG. 21, the battery assemblies 400, 410, 420, 430 may comprise atest circuit 457 a comprising a switch 457 b and a resistor 457 c suchthat when the switch 457 b is closed (e.g., via the test button 426),the resistor 457 c tests whether the primary batteries 452 a-d arecapable of delivering the output voltage V_(o). Otherwise, the resistor457 tests whether the secondary battery 454, via operation of the switchmode power supply 456, is capable of delivering a V_(b) such thatsupplemental current passing through the diode 458 restores the outputvoltage V_(o).

FIG. 22 illustrates a switch mode power supply circuit 460 for supplyingenergy to the surgical instrument 100, according to one aspect of thepresent disclosure. The switch mode power supply circuit 460 may bedisposed within any one of the battery assemblies 400, 410, 430described in connection with FIGS. 16, 17, and 19, respectively. In theillustrated example, the switch mode power supply circuit 460 comprisesprimary Li cell batteries 429 a-d where the positive (+) output voltageis coupled to an input terminal V_(IN) of a switching regulator 464. Itwill be appreciated that any suitable number of primary cells may beemployed. The switch mode power supply circuit 460 includes a remoteON/OFF switch. The input V_(IN) of the switching regulator 464 alsoincludes an input filter represented by capacitor C. The output V_(OUT)of the switching regulator 464 is coupled to an inductor L and an outputfilter represented by capacitor C_(o). A catch diode D is disposedbetween V_(OUT) and ground. A feedback signal is provided from theoutput filter C_(o) to the FB input of the switching regulator 464. Aload resistor R_(L) represents a load. In one aspect, the minimum loadis about 200 mA. In one aspect, the output voltage V_(OUT) is 3.3 VDC at800 mA.

FIG. 23 illustrates a discrete version of the switching regulator 464shown in FIG. 22 for supplying energy to the surgical instrument 100,according to one aspect of the present disclosure. The switchingregulator 464 receives the input voltage from a battery assembly 400,410, 420, 430 at the V_(IN) terminal. The signal at the ON/OFF inputenables or disables the operation of the switching regulator 464 bycontrolling the state of the switch 471. A feedback signal is receivedfrom the load at the FB input where is divided by a voltage dividercircuit 463. The voltage from the voltage divider 463 is applied to thepositive input of a fixed gain amplifier 465. The negative input of thefixed gain amplifier 465 is coupled to a bandgap reference diode 469(e.g., 1.23V). The amplified output of the fixed gain amplifier 465 isapplied to the positive input of a comparator 466. The negative input ofthe comparator 466 receives a 50 kHz oscillator 467 input. The output ofthe comparator 466 is applied to a driver 468 which drives and outputtransistor 461. The output transistor 461 supplies voltage and currentto the load via the V_(OUT) terminal.

FIG. 24 illustrates a linear power supply circuit 470 for supplyingenergy to the surgical instrument 100, according to one aspect of thepresent disclosure. The linear power supply circuit 470 may be disposedwithin any one of the battery assemblies 400, 410, 420, 430 described inconnection with FIGS. 16, 17, 18, and 19, respectively. In theillustrated example, the linear power supply circuit 470 comprisesprimary Li-ion cell batteries 462 a-d where the positive (+) outputvoltage is coupled to the V_(IN) terminal of transistor 472. The outputof the transistor 472 supplies the current and voltage to the load viathe V_(OUT) terminal of the linear power supply circuit 470. An inputfilter C_(i) is provided at the input side and an output filter C_(o) isprovided at an output side. A Zener diode D_(Z) applies a regulatedvoltage to the base of the transistor 472. A bias resistor biases theZener diode D_(Z) and the transistor 472.

FIG. 25 is an elevational exploded view of modular handheld ultrasonicsurgical instrument 480 showing the left shell half removed from ahandle assembly 482 exposing a device identifier communicatively coupledto the multi-lead handle terminal assembly in accordance with one aspectof the present disclosure. In additional aspects of the presentdisclosure, an intelligent or smart battery is used to power the modularhandheld ultrasonic surgical instrument 480. However, the smart batteryis not limited to the modular handheld ultrasonic surgical instrument480 and, as will be explained, can be used in a variety of devices,which may or may not have power requirements (e.g., current and voltage)that vary from one another. The smart battery assembly 486, inaccordance with one aspect of the present disclosure, is advantageouslyable to identify the particular device to which it is electricallycoupled. It does this through encrypted or unencrypted identificationmethods. For instance, a smart battery assembly 486 can have aconnection portion, such as connection portion 488. The handle assembly482 can also be provided with a device identifier communicativelycoupled to the multi-lead handle terminal assembly 491 and operable tocommunicate at least one piece of information about the handle assembly482. This information can pertain to the number of times the handleassembly 482 has been used, the number of times an ultrasonictransducer/generator assembly 484 (presently disconnected from thehandle assembly 482) has been used, the number of times a waveguideshaft assembly 490 (presently connected to the handle assembly 482) hasbeen used, the type of the waveguide shaft assembly 490 that ispresently connected to the handle assembly 482, the type or identity ofthe ultrasonic transducer/generator assembly 484 that is presentlyconnected to the handle assembly 482, and/or many other characteristics.When the smart battery assembly 486 is inserted in the handle assembly482, the connection portion 488 within the smart battery assembly 486makes communicating contact with the device identifier of the handleassembly 482. The handle assembly 482, through hardware, software, or acombination thereof, is able to transmit information to the smartbattery assembly 486 (whether by self-initiation or in response to arequest from the smart battery assembly 486). This communicatedidentifier is received by the connection portion 488 of the smartbattery assembly 486. In one aspect, once the smart battery assembly 486receives the information, the communication portion is operable tocontrol the output of the smart battery assembly 486 to comply with thedevice's specific power requirements.

In one aspect, the communication portion includes a processor 493 and amemory 497, which may be separate or a single component. The processor493, in combination with the memory, is able to provide intelligentpower management for the modular handheld ultrasonic surgical instrument480. This aspect is particularly advantageous because an ultrasonicdevice, such as the modular handheld ultrasonic surgical instrument 480,has a power requirement (frequency, current, and voltage) that may beunique to the modular handheld ultrasonic surgical instrument 480. Infact, the modular handheld ultrasonic surgical instrument 480 may have aparticular power requirement or limitation for one dimension or type ofouter tube 494 and a second different power requirement for a secondtype of waveguide having a different dimension, shape, and/orconfiguration.

A smart battery assembly 486, according to one aspect of the presentdisclosure, therefore, allows a battery assembly to be used amongstseveral surgical instruments. Because the smart battery assembly 486 isable to identify to which device it is attached and is able to alter itsoutput accordingly, the operators of various different surgicalinstruments utilizing the smart battery assembly 486 no longer need beconcerned about which power source they are attempting to install withinthe electronic device being used. This is particularly advantageous inan operating environment where a battery assembly needs to be replacedor interchanged with another surgical instrument in the middle of acomplex surgical procedure.

In a further aspect of the present disclosure, the smart batteryassembly 486 stores in a memory 497 a record of each time a particulardevice is used. This record can be useful for assessing the end of adevice's useful or permitted life. For instance, once a device is used20 times, such batteries in the smart battery assembly 486 connected tothe device will refuse to supply power thereto—because the device isdefined as a “no longer reliable” surgical instrument. Reliability isdetermined based on a number of factors. One factor can be wear, whichcan be estimated in a number of ways including the number of times thedevice has been used or activated. After a certain number of uses, theparts of the device can become worn and tolerances between partsexceeded. For instance, the smart battery assembly 486 can sense thenumber of button pushes received by the handle assembly 482 and candetermine when a maximum number of button pushes has been met orexceeded. The smart battery assembly 486 can also monitor an impedanceof the button mechanism which can change, for instance, if the handlegets contaminated, for example, with saline.

This wear can lead to an unacceptable failure during a procedure. Insome aspects, the smart battery assembly 486 can recognize which partsare combined together in a device and even how many uses a part hasexperienced. For instance, if the smart battery assembly 486 is a smartbattery according to the present disclosure, it can identify the handleassembly 482, the waveguide shaft assembly 490, as well as theultrasonic transducer/generator assembly 484, well before the userattempts use of the composite device. The memory 497 within the smartbattery assembly 486 can, for example, record a time when the ultrasonictransducer/generator assembly 484 is operated, and how, when, and forhow long it is operated. If the ultrasonic transducer/generator assembly484 has an individual identifier, the smart battery assembly 486 cankeep track of uses of the ultrasonic transducer/generator assembly 484and refuse to supply power to that the ultrasonic transducer/generatorassembly 484 once the handle assembly 482 or the ultrasonictransducer/generator assembly 484 exceeds its maximum number of uses.The ultrasonic transducer/generator assembly 484, the handle assembly482, the waveguide shaft assembly 490, or other components can include amemory chip that records this information as well. In this way, anynumber of smart batteries in the smart battery assembly 486 can be usedwith any number of ultrasonic transducer/generator assemblies 484,staplers, vessel sealers, etc. and still be able to determine the totalnumber of uses, or the total time of use (through use of the clock), orthe total number of actuations, etc. of the ultrasonictransducer/generator assembly 484, the stapler, the vessel sealer, etc.or charge or discharge cycles. Smart functionality may reside outsidethe battery assembly 486 and may reside in the handle assembly 482, theultrasonic transducer/generator assembly 484, and/or the shaft assembly490, for example.

When counting uses of the ultrasonic transducer/generator assembly 484,to intelligently terminate the life of the ultrasonictransducer/generator assembly 484, the surgical instrument accuratelydistinguishes between completion of an actual use of the ultrasonictransducer/generator assembly 484 in a surgical procedure and amomentary lapse in actuation of the ultrasonic transducer/generatorassembly 484 due to, for example, a battery change or a temporary delayin the surgical procedure. Therefore, as an alternative to simplycounting the number of activations of the ultrasonictransducer/generator assembly 484, a real-time clock (RTC) circuit canbe implemented to keep track of the amount of time the ultrasonictransducer/generator assembly 484 actually is shut down. From the lengthof time measured, it can be determined through appropriate logic if theshutdown was significant enough to be considered the end of one actualuse or if the shutdown was too short in time to be considered the end ofone use. Thus, in some applications, this method may be a more accuratedetermination of the useful life of the ultrasonic transducer/generatorassembly 484 than a simple “activations-based” algorithm, which forexample, may provide that ten “activations” occur in a surgicalprocedure and, therefore, ten activations should indicate that thecounter is incremented by one. Generally, this type and system ofinternal clocking will prevent misuse of the device that is designed todeceive a simple “activations-based” algorithm and will preventincorrect logging of a complete use in instances when there was only asimple de-mating of the ultrasonic transducer/generator assembly 484 orthe smart battery assembly 486 that was required for legitimate reasons.

Although the ultrasonic transducer/generator assemblies 484 of thesurgical instrument 480 are reusable, in one aspect a finite number ofuses may be set because the surgical instrument 480 is subjected toharsh conditions during cleaning and sterilization. More specifically,the battery pack is configured to be sterilized. Regardless of thematerial employed for the outer surfaces, there is a limited expectedlife for the actual materials used. This life is determined by variouscharacteristics which could include, for example, the amount of timesthe pack has actually been sterilized, the time from which the pack wasmanufactured, and the number of times the pack has been recharged, toname a few. Also, the life of the battery cells themselves is limited.Software of the present disclosure incorporates inventive algorithmsthat verify the number of uses of the ultrasonic transducer/generatorassembly 484 and smart battery assembly 486 and disables the device whenthis number of uses has been reached or exceeded. Analysis of thebattery pack exterior in each of the possible sterilizing methods can beperformed. Based on the harshest sterilization procedure, a maximumnumber of permitted sterilizations can be defined and that number can bestored in a memory of the smart battery assembly 486. If it is assumedthat a charger is non-sterile and that the smart battery assembly 486 isto be used after it is charged, then the charge count can be defined asbeing equal to the number of sterilizations encountered by thatparticular pack.

In one aspect, the hardware in the battery pack may be to disabled tominimize or eliminate safety concerns due to continuous drain in fromthe battery cells after the pack has been disabled by software. Asituation can exist where the battery's internal hardware is incapableof disabling the battery under certain low voltage conditions. In such asituation, in an aspect, the charger can be used to “kill” the battery.Due to the fact that the battery microcontroller is OFF while thebattery is in its charger, a non-volatile, System Management Bus (SMB)based electrically erasable programmable read only memory (EEPROM) canbe used to exchange information between the battery microcontroller andthe charger. Thus, a serial EEPROM can be used to store information thatcan be written and read even when the battery microcontroller is OFF,which is very beneficial when trying to exchange information with thecharger or other peripheral devices. This example EEPROM can beconfigured to contain enough memory registers to store at least (a) ause-count limit at which point the battery should be disabled (BatteryUse Count), (b) the number of procedures the battery has undergone(Battery Procedure Count), and/or (c) a number of charges the batteryhas undergone (Charge Count), to name a few. Some of the informationstored in the EEPROM, such as the Use Count Register and Charge CountRegister are stored in write-protected sections of the EEPROM to preventusers from altering the information. In an aspect, the use and countersare stored with corresponding bit-inverted minor registers to detectdata corruption.

Any residual voltage in the SMBus lines could damage the microcontrollerand corrupt the SMBus signal. Therefore, to ensure that the SMBus linesof the battery controller 703 do not carry a voltage while themicrocontroller is OFF, relays are provided between the external SMBuslines and the battery microcontroller board.

During charging of the smart battery assembly 486, an “end-of-charge”condition of the batteries within the smart battery assembly 486 isdetermined when, for example, the current flowing into the battery fallsbelow a given threshold in a tapering manner when employing aconstant-current/constant-voltage charging scheme. To accurately detectthis “end-of-charge” condition, the battery microcontroller and buckboards are powered down and turned OFF during charging of the battery toreduce any current drain that may be caused by the boards and that mayinterfere with the tapering current detection. Additionally, themicrocontroller and buck boards are powered down during charging toprevent any resulting corruption of the SMBus signal.

With regard to the charger, in one aspect the smart battery assembly 486is prevented from being inserted into the charger in any way other thanthe correct insertion position. Accordingly, the exterior of the smartbattery assembly 486 is provided with charger-holding features. A cupfor holding the smart battery assembly 486 securely in the charger isconfigured with a contour-matching taper geometry to prevent theaccidental insertion of the smart battery assembly 486 in any way otherthan the correct (intended) way. It is further contemplated that thepresence of the smart battery assembly 486 may be detectable by thecharger itself. For example, the charger may be configured to detect thepresence of the SMBus transmission from the battery protection circuit,as well as resistors that are located in the protection board. In suchcase, the charger would be enabled to control the voltage that isexposed at the charger's pins until the smart battery assembly 486 iscorrectly seated or in place at the charger. This is because an exposedvoltage at the charger's pins would present a hazard and a risk that anelectrical short could occur across the pins and cause the charger toinadvertently begin charging.

In some aspects, the smart battery assembly 486 can communicate to theuser through audio and/or visual feedback. For example, the smartbattery assembly 486 can cause the LEDs to light in a pre-set way. Insuch a case, even though the microcontroller in the ultrasonictransducer/generator assembly 484 controls the LEDs, the microcontrollerreceives instructions to be carried out directly from the smart batteryassembly 486.

In yet a further aspect of the present disclosure, the microcontrollerin the ultrasonic transducer/generator assembly 484, when not in use fora predetermined period of time, goes into a sleep mode. Advantageously,when in the sleep mode, the clock speed of the microcontroller isreduced, cutting the current drain significantly. Some current continuesto be consumed because the processor continues pinging waiting to sensean input. Advantageously, when the microcontroller is in thispower-saving sleep mode, the microcontroller and the battery controllercan directly control the LEDs. For example, a decoder circuit could bebuilt into the ultrasonic transducer/generator assembly 484 andconnected to the communication lines such that the LEDs can becontrolled independently by the processor 493 while the ultrasonictransducer/generator assembly 484 microcontroller is “OFF” or in a“sleep mode.” This is a power-saving feature that eliminates the needfor waking up the microcontroller in the ultrasonic transducer/generatorassembly 484. Power is conserved by allowing the generator to be turnedoff while still being able to actively control the user-interfaceindicators.

Another aspect slows down one or more of the microcontrollers toconserve power when not in use. For example, the clock frequencies ofboth microcontrollers can be reduced to save power. To maintainsynchronized operation, the microcontrollers coordinate the changing oftheir respective clock frequencies to occur at about the same time, boththe reduction and, then, the subsequent increase in frequency when fullspeed operation is required. For example, when entering the idle mode,the clock frequencies are decreased and, when exiting the idle mode, thefrequencies are increased.

In an additional aspect, the smart battery assembly 486 is able todetermine the amount of usable power left within its cells and isprogrammed to only operate the surgical instrument to which it isattached if it determines there is enough battery power remaining topredictably operate the device throughout the anticipated procedure. Forexample, the smart battery assembly 486 is able to remain in anon-operational state if there is not enough power within the cells tooperate the surgical instrument for 20 seconds. According to one aspect,the smart battery assembly 486 determines the amount of power remainingwithin the cells at the end of its most recent preceding function, e.g.,a surgical cutting. In this aspect, therefore, the smart batteryassembly 486 would not allow a subsequent function to be carried out if,for example, during that procedure, it determines that the cells haveinsufficient power. Alternatively, if the smart battery assembly 486determines that there is sufficient power for a subsequent procedure andgoes below that threshold during the procedure, it would not interruptthe ongoing procedure and, instead, will allow it to finish andthereafter prevent additional procedures from occurring.

The following explains an advantage to maximizing use of the device withthe smart battery assembly 486 of the present disclosure. In thisexample, a set of different devices have different ultrasonictransmission waveguides. By definition, the waveguides could have arespective maximum allowable power limit where exceeding that powerlimit overstresses the waveguide and eventually causes it to fracture.One waveguide from the set of waveguides will naturally have thesmallest maximum power tolerance. Because prior-art batteries lackintelligent battery power management, the output of prior-art batteriesmust be limited by a value of the smallest maximum allowable power inputfor the smallest/thinnest/most-frail waveguide in the set that isenvisioned to be used with the device/battery. This would be true eventhough larger, thicker waveguides could later be attached to that handleand, by definition, allow a greater force to be applied. This limitationis also true for maximum battery power. For example, if one battery isdesigned to be used in multiple devices, its maximum output power willbe limited to the lowest maximum power rating of any of the devices inwhich it is to be used. With such a configuration, one or more devicesor device configurations would not be able to maximize use of thebattery because the battery does not know the particular device'sspecific limits.

In one aspect, the smart battery assembly 486 may be employed tointelligently circumvent the above-mentioned ultrasonic devicelimitations. The smart battery assembly 486 can produce one output forone device or a particular device configuration and the same smartbattery assembly 486 can later produce a different output for a seconddevice or device configuration. This universal smart battery surgicalsystem lends itself well to the modern operating room where space andtime are at a premium. By having a smart battery pack operate manydifferent devices, the nurses can easily manage the storage, retrieval,and inventory of these packs. Advantageously, in one aspect the smartbattery system according to the present disclosure may employ one typeof charging station, thus increasing ease and efficiency of use anddecreasing cost of surgical room charging equipment.

In addition, other surgical instruments, such as an electric stapler,may have a different power requirement than that of the modular handheldultrasonic surgical instrument 480. In accordance with various aspectsof the present disclosure, a smart battery assembly 486 can be used withany one of a series of surgical instruments and can be made to tailorits own power output to the particular device in which it is installed.In one aspect, this power tailoring is performed by controlling the dutycycle of a switched mode power supply, such as buck, buck-boost, boost,or other configuration, integral with or otherwise coupled to andcontrolled by the smart battery assembly 486. In other aspects, thesmart battery assembly 486 can dynamically change its power outputduring device operation. For instance, in vessel sealing devices, powermanagement provides improved tissue sealing. In these devices, largeconstant current values are needed. The total power output needs to beadjusted dynamically because, as the tissue is sealed, its impedancechanges. Aspects of the present disclosure provide the smart batteryassembly 486 with a variable maximum current limit. The current limitcan vary from one application (or device) to another, based on therequirements of the application or device.

FIG. 26 is a detail view of a trigger 483 portion and switch of theultrasonic surgical instrument 480 shown in FIG. 25, according to oneaspect of the present disclosure. The trigger 483 is operably coupled tothe jaw member 495 of the end effector 492. The ultrasonic blade 496 isenergized by the ultrasonic transducer/generator assembly 484 uponactivating the activation switch 485. Continuing now with FIG. 25 andalso looking to FIG. 26, the trigger 483 and the activation switch 485are shown as components of the handle assembly 482. The trigger 483activates the end effector 492, which has a cooperative association withthe ultrasonic blade 496 of the waveguide shaft assembly 490 to enablevarious kinds of contact between the end effector jaw member 495 and theultrasonic blade 496 with tissue and/or other substances. The jaw member495 of the end effector 492 is usually a pivoting jaw that acts to graspor clamp onto tissue disposed between the jaw and the ultrasonic blade496. In one aspect, an audible feedback is provided in the trigger thatclicks when the trigger is fully depressed. The noise can be generatedby a thin metal part that the trigger snaps over while closing. Thisfeature adds an audible component to user feedback that informs the userthat the jaw is fully compressed against the waveguide and thatsufficient clamping pressure is being applied to accomplish vesselsealing. In another aspect, force sensors such as strain gages orpressure sensors may be coupled to the trigger 483 to measure the forceapplied to the trigger 483 by the user. In another aspect, force sensorssuch as strain gages or pressure sensors may be coupled to the switch485 button such that displacement intensity corresponds to the forceapplied by the user to the switch 485 button.

The activation switch 485, when depressed, places the modular handheldultrasonic surgical instrument 480 into an ultrasonic operating mode,which causes ultrasonic motion at the waveguide shaft assembly 490. Inone aspect, depression of the activation switch 485 causes electricalcontacts within a switch to close, thereby completing a circuit betweenthe smart battery assembly 486 and the ultrasonic transducer/generatorassembly 484 so that electrical power is applied to the ultrasonictransducer, as previously described. In another aspect, depression ofthe activation switch 485 closes electrical contacts to the smartbattery assembly 486. Of course, the description of closing electricalcontacts in a circuit is, here, merely an example general description ofswitch operation. There are many alternative aspects that can includeopening contacts or processor-controlled power delivery that receivesinformation from the switch and directs a corresponding circuit reactionbased on the information.

FIG. 27 is a fragmentary, enlarged perspective view of an end effector492, according to one aspect of the present disclosure, from a distalend with a jaw member 495 in an open position. Referring to FIG. 27, aperspective partial view of the distal end 498 of the waveguide shaftassembly 490 is shown. The waveguide shaft assembly 490 includes anouter tube 494 surrounding a portion of the waveguide. The ultrasonicblade 496 portion of the waveguide 499 protrudes from the distal end 498of the outer tube 494. It is the ultrasonic blade 496 portion thatcontacts the tissue during a medical procedure and transfers itsultrasonic energy to the tissue. The waveguide shaft assembly 490 alsoincludes a jaw member 495 that is coupled to the outer tube 494 and aninner tube (not visible in this view). The jaw member 495, together withthe inner and outer tubes and the ultrasonic blade 496 portion of thewaveguide 499, can be referred to as an end effector 492. As will beexplained below, the outer tube 494 and the non-illustrated inner tubeslide longitudinally with respect to each other. As the relativemovement between the outer tube 494 and the non-illustrated inner tubeoccurs, the jaw member 495 pivots upon a pivot point, thereby causingthe jaw member 495 to open and close. When closed, the jaw member 495imparts a pinching force on tissue located between the jaw member 495and the ultrasonic blade 496, insuring positive and efficientblade-to-tissue contact.

FIG. 28 illustrates a modular shaft assembly 110 and end effector 112portions of the surgical instrument 100, according to one aspect of thepresent disclosure. The shaft assembly 110 comprises an outer tube 144,an inner tube 147, and an ultrasonic transmission waveguide 145. Theshaft assembly 110 is removably mounted to the handle assembly 102. Theinner tube 147 is slidably received within the outer tube 144. Theultrasonic transmission waveguide 145 is positioned within the innertube 147. The jaw member 114 of the end effector 112 is pivotallycoupled to the outer tube 144 at a pivot point 151. The jaw member 114also is coupled to inner tube 147 by a pin 153 such that as the innertube 147 slides within the slot 155, the jaw member opens and closes. Inthe illustrated configuration, the inner tube 147 is in its distalposition and the jaw member 114 is open. To close the jaw member 114,the inner tube 147 is retracted in the proximal direction 157 and toopen the jaw member is advanced in the distal direction 159. Theproximal end of the shaft assembly 110 comprises a jaw member tube(e.g., inner tube)/spring assembly 141. A spring 139 is provided toapply a constant force control mechanism for use with different shaftassemblies, motor closures to control constant force closures, two barmechanism to drive closure systems, cam lobes to push and pull closuresystem, drive screw designs to drive closure or wave spring designs tocontrol constant force.

FIG. 29 is a detail view of the inner tube/spring assembly 141. Aclosure mechanism 149 is operably coupled to the trigger 108 (FIGS.1-3). Accordingly, as the trigger 108 is squeezed, the inner tube 143 isretracted in the proximal direction 157 to close the jaw member 114.Accordingly, as the trigger 108 is released, the inner tube 143 isadvanced in the distal direction 159 to open the jaw member 114.

For a more detailed description of a combinationultrasonic/electrosurgical instrument, reference is made to U.S. Pat.No. 9,107,690, which is herein incorporated by reference.

FIG. 30 illustrates a modular battery powered handheld combinationultrasonic/electrosurgical instrument 500, according to one aspect ofthe present disclosure. FIG. 31 is an exploded view of the surgicalinstrument 500 shown in FIG. 30, according to one aspect of the presentdisclosure. With reference now to FIGS. 30 and 31, the surgicalinstrument 500 comprises a handle assembly 502, an ultrasonictransducer/RF generator assembly 504, a battery assembly 506, a shaftassembly 510, and an end effector 512. The ultrasonic transducer/RFgenerator assembly 504, battery assembly 506, and shaft assembly 510 aremodular components that are removably connectable to the handle assembly502. The handle assembly 502 also comprises a motor assembly 560. Thesurgical instrument 500 is configured to use both ultrasonic vibrationand electrosurgical high-frequency current to carry out surgicalcoagulation/cutting treatments on living tissue, and uses high-frequencycurrent to carry out a surgical coagulation treatment on living tissue.The ultrasonic vibrations and the high-frequency (e.g., RF) current canbe applied independently or in combination according to algorithms oruser input control.

The ultrasonic transducer/RF generator assembly 504 comprises a housing548, a display 576, such as an LCD display, for example, an ultrasonictransducer 530, an electrical circuit 177 (FIGS. 4, 10 and/or electricalcircuit 300 in FIG. 14), and a electrical circuit 702 (FIG. 34)configured to drive an RF electrode and forms a portion of an RFgenerator circuit. The shaft assembly 510 comprises an outer tube 544 anultrasonic transmission waveguide 545, and an inner tube (not shown).The end effector 512 comprises a jaw member 514 and an ultrasonic blade516. The jaw member 514 comprises an electrode 515 that is coupled to anRF generator circuit. The ultrasonic blade 516 is the distal end of theultrasonic transmission waveguide 545. The jaw member 514 is pivotallyrotatable to grasp tissue between the jaw member 514 and the ultrasonicblade 516. The jaw member 514 is operably coupled to a trigger 508. Thetrigger 508 functions to close the jaw member 514 when the trigger 508is squeezed and to open the jaw member 514 when the trigger 508 isreleased to release the tissue. In a one-stage trigger configuration,the trigger 508 is squeezed to close the jaw member 514 and, once thejaw member 514 is closed, a first switch 521 a of a switch section isactivated to energize the RF generator to seal the tissue. After thetissue is sealed, a second switch 521 b of the switch section 520 isactivated to energize the ultrasonic generator to cut the tissue. Invarious aspects, the trigger 508 may be a two-stage, or a multi-stage,trigger. In a two-stage trigger configuration, during the first stage,the trigger 508 is squeezed part of the way to close the jaw member 514and, during the second stage, the trigger 508 is squeezed the rest ofthe way to energize the RF generator circuit to seal the tissue. Afterthe tissue is sealed, one of the switches 521 a, 521 b can be activatedto energize the ultrasonic generator to cut the tissue. After the tissueis cut, the jaw member 514 is opened by releasing the trigger 508 torelease the tissue. In another aspect, force sensors such as straingages or pressure sensors may be coupled to the trigger 508 to measurethe force applied to the trigger 508 by the user. In another aspect,force sensors such as strain gages or pressure sensors may be coupled tothe switch 520 button such that displacement intensity corresponds tothe force applied by the user to the switch 520 button.

The battery assembly 506 is electrically connected to the handleassembly 502 by an electrical connector 532. The handle assembly 502 isprovided with a switch section 520. A first switch 520 a and a secondswitch 520 b are provided in the switch section 520. The RF generator isactivated by actuating the first switch 520 a and the ultrasonic blade516 is activated by actuating the second switch 520 b. Accordingly, thefirst switch 520 a energizes the RF circuit to drive high-frequencycurrent through the tissue to form a seal and the second switch 520 benergizes the ultrasonic transducer 530 to vibrate the ultrasonic blade516 and cut the tissue.

A rotation knob 518 is operably coupled to the shaft assembly 510.Rotation of the rotation knob 518 ±360° in the direction indicated bythe arrows 526 causes an outer tube 544 to rotate ±360° in therespective direction of the arrows 528. In one aspect, another rotationknob 522 may be configured to rotate the jaw member 514 while theultrasonic blade 516 remains stationary and the rotation knob 518rotates the outer tube 144 ±360°. The outer tube 144 may have a diameterD₁ ranging from 5 mm to 10 mm, for example.

FIG. 32 is a partial perspective view of a modular battery poweredhandheld combination ultrasonic/RF surgical instrument 600, according toone aspect of the present disclosure. The surgical instrument 600 isconfigured to use both ultrasonic vibration and high-frequency currentto carry out surgical coagulation/cutting treatments on living tissue,and uses high-frequency current to carry out a surgical coagulationtreatment on living tissue. The ultrasonic vibrations and thehigh-frequency (e.g., RF) current can be applied independently or incombination according to algorithms or user input control. The surgicalinstrument 600 comprises a handle assembly 602, an ultrasonictransducer/RF generator assembly 604, a battery assembly 606, a shaftassembly (not shown), and an end effector (not shown). The ultrasonictransducer/RF generator assembly 604, battery assembly 606, and shaftassembly are modular components that are removably connectable to thehandle assembly 602. A trigger 608 is operatively coupled to the handleassembly 602. As previously described, the trigger operates the endeffector.

The ultrasonic transducer/RF generator assembly 604 comprises a housing648, a display 676, such as an LCD display, for example. The display 676provides a visual display of surgical procedure parameters such astissue thickness, status of seal, status of cut, tissue thickness,tissue impedance, algorithm being executed, battery capacity, energybeing applied (either ultrasonic vibration or RF current), among otherparameters. The ultrasonic transducer/RF generator assembly 604 alsocomprises two visual feedback indicators 678, 679 to indicate the energymodality currently being applied in the surgical procedure. For example,one indicator 678 shows when RF energy is being used and anotherindicator 679 shows when ultrasonic energy is being used. It will beappreciated that when both energy modalities RF and ultrasonic are beingapplied, both indicators will show this condition. The surgicalinstrument 600 also comprises an ultrasonic transducer, an ultrasonicgenerator circuit and/or electrical circuit, a shaft assembly, and anend effector comprising a jaw member and an ultrasonic blade, themodular components being similar to those described in connection withFIGS. 30 and 31 and the description will not be repeated here forconciseness and clarity of disclosure.

The battery assembly 606 is electrically connected to the handleassembly 602 by an electrical connector. The handle assembly 602 isprovided with a switch section 620. A first switch 620 a and a secondswitch 620 b are provided in the switch section 620. The ultrasonicblade is activated by actuating the first switch 620 a and the RFgenerator is activated by actuating the second switch 620 b. In anotheraspect, force sensors such as strain gages or pressure sensors may becoupled to the trigger 608 to measure the force applied to the trigger608 by the user. In another aspect, force sensors such as strain gagesor pressure sensors may be coupled to the switch 620 button such thatdisplacement intensity corresponds to the force applied by the user tothe switch 620 button.

A rotation knob 618 is operably coupled to the shaft assembly. Rotationof the rotation knob 618 ±360° causes an outer tube to rotate ±360° inthe respective direction, as described herein in connection with FIGS.30 and 31. In one aspect, another rotation knob may be configured torotate the jaw member while the ultrasonic blade remains stationary andthe rotation knob 618 rotates the outer tube ±360°. A button 673 is usedto connect and retain the shaft assembly to the handle assembly 602.Another slide switch 675 is used to lock in and release the ultrasonictransducer/RF generator assembly 604.

In one aspect, the surgical instrument 500, 600 includes a batterypowered advanced energy (ultrasonic vibration plus high-frequencycurrent) with driver amplification broken into multiple stages. Thedifferent stages of amplification may reside in different modularcomponents of the surgical instrument 500, 600 such as the handleassembly 502, 602 ultrasonic transducer/RF generator assembly 504, 604,battery assembly 506, 606, shaft assembly 510, and/or the end effector112. In one aspect, the ultrasonic transducer/RF generator assembly 504,604 may include an amplification stage in the ultrasonic transducerand/or RF electronic circuits within the housing 548, 648 and differentratios of amplification based on the energy modality associated with theparticular energy mode. The final stage may be controlled via signalsfrom the electronic system of the surgical instrument 100 located in thehandle assembly 502, 602 and/or the battery assembly 506, 606 through abus structure, such as I²C, as previously described. Final stageswitches system may be employed to apply power to the transformer andblocking capacitors to form the RF waveform. Measurements of the RFoutput, such as voltage and current, are fed back to the electronicsystem over the bus. The handle assembly 502, 602 and/or batteryassembly 506, 606 may contain the majority of the primary amplificationcircuits including any electrical isolation components, motor control,and waveform generator. The two differing ultrasonic transducers (e.g.,ultrasonic transducer 130, 130′ shown in FIGS. 8 and 9) and the RFtransducer contain the electronics to utilize the preconditionsgenerator signals and perform the final conditioning to power differentfrequency transducers of RF signals in the desired frequency ranges andamplitudes. This minimizes the weight size and cost of the electronicsresiding only in the transducers themselves. It also allows the primaryprocessor boards to occupy the areas of the handle that have the mostuseful space which is rarely where the transducer is, due to its size.It also allows the electronics to be divided in such a way as the highwear high duty cycle elements could be only connectively attached to theprimary electronics enabling it to be more serviceable and repairablesince the system is designed for high repeated use before disposal.

The surgical instruments 500, 600 described in connection with FIGS.30-32 are configured to use high-frequency current to carry out surgicalcoagulation/cutting treatments on living tissue, and uses high-frequencycurrent to carry out a surgical coagulation treatment on living tissue.Accordingly, additional structural and functional components to carryout this additional functionality will be described hereinbelow inconnection with FIGS. 33-44.

The structural and functional aspects of the battery assembly 506, 606are similar to those of the battery assembly 106 for the surgicalinstrument 100 described in connection with FIGS. 1, 2, and 16-24,including the battery circuits described in connection with FIGS. 20-24.Accordingly, for conciseness and clarity of disclosure, such thestructural and functional aspects of the battery assembly 106 areincorporated herein by reference and will not be repeated here.Similarly, unless otherwise noted, the structural and functional aspectsof the shaft assembly 510 are similar to those of the shaft assembly 110for the surgical instrument 100 described in connection with FIGS. 1-3.Accordingly, for conciseness and clarity of disclosure, such thestructural and functional aspects of the shaft assembly 110 areincorporated herein by reference and will not be repeated here.Furthermore, the structural and functional aspects of the ultrasonictransducer 530 generator circuits are similar to those of the ultrasonictransducer 130 generator circuits for the surgical instrument 100described in connection with FIGS. 1, 2, and 4-15. Accordingly, forconciseness and clarity of disclosure, such the structural andfunctional aspects of the ultrasonic transducer 130 and generatorcircuits are incorporated herein by reference and will not be repeatedhere. Furthermore, the surgical instruments 500, 600 include thecircuits described in connection with FIGS. 12-15, including, forexample, the control circuit 210 described in connection with FIG. 14and the electrical circuit 300 described in connection with FIG. 15.Accordingly, for conciseness and clarity of disclosure, the descriptionof the circuits described in connection with FIGS. 12-15 is incorporatedherein by reference and will not be repeated here.

Turning now to FIG. 33, there is shown a nozzle 700 portion of thesurgical instruments 500, 600 described in connection with FIGS. 30-32,according to one aspect of the present disclosure. The nozzle 700contains an electrical circuit 702 configured to drive thehigh-frequency RF current to an electrode located in the end effector asdescribed hereinbelow in connection with FIGS. 38-44. The electricalcircuit 702 is coupled to the primary winding of a transformer 704. Thepositive side of the secondary winding of the transformer 704 is coupledto series connected first and second blocking capacitors 706, 708. Theload side of the second blocking capacitor 708 is coupled to thepositive RF(+) terminal which is coupled to the positive side of the endeffector electrode. The negative side of the secondary winding of thetransformer 704 is coupled to the negative RF(−) terminal, otherwisereferred to as ground. It will be appreciated that the RF(−) or groundterminal of the RF energy circuit is coupled to an outer tube 744, whichis formed of an electrically conductive metal. Accordingly, in use,high-frequency current is conducted from the end effector electrodeRF(+), through the tissue, and returns through the negative electrodeRF(−).

With reference now also to FIGS. 30, 31, in one aspect, the outer tube744 is operably coupled to the jaw member 514 portion of the endeffector 512 such that the jaw member 514 opens when the outer tube 744is advanced in the distal direction 722 and the jaw member 514 closeswhen the outer tube 744 is retracted in the proximal direction 724.Although not shown in FIG. 33, the outer tube 744 is operably coupled tothe trigger 508, which is used to open and close the jaw member 514portion of the end effector 512. Examples of actuation mechanisms foruse with ultrasonic surgical instruments as described herein aredisclosed in U.S. Pub. No. 2006/0079879 and U.S. Pub. No. 2015/0164532,each of which is herein incorporated by reference.

Still with reference to FIGS. 30, 31, and 33, in one aspect, an innertube 714 is slidably disposed within the outer tube 744. The inner tube714 is operably coupled to the jaw member 514 to rotate the jaw member514 while maintaining the ultrasonic blade 516 stationary. In the aspectshown in FIGS. 30 and 31 the inner tube 714 is rotated by the rotationknob 522. In the aspect shown in FIG. 33, a motor 719 may be providedwithin the handle assembly 502 to engage a gear 721 on the proximal endof the outer tube 744, optionally through an idler gear 725.

Still with reference to FIGS. 30, 31, and 33, in one aspect, an innerelectrically insulative (e.g., rubber, plastic) tube 716 is slidablydisposed within the inner tube 714. A flex circuit 728 may be disposedwithin the inner electrically insulative tube 716 to electrically coupleenergy and sensor circuits to the end effector 512. For example, the jawmember 514 may comprise an electrode coupled to conductors in the flexcircuit 728. In other aspects, the end effector 512, jaw member 514, orthe ultrasonic blade 516 may comprise various sensors or otherelectrical elements that can be interconnected to electrical circuitsand components in the shaft assembly 510, the handle assembly 502, theultrasonic transducer/RF generator assembly 504, and/or the batteryassembly 506, for example.

Still with reference to FIGS. 30, 31, and 33, in one aspect, theultrasonic transmission waveguide 545 (shown in FIG. 32 only; not shownin FIG. 33 for clarity) is disposed within the inner electricallyinsulative tube 716. In one aspect, the positive electrode RF(+) of theelectrical circuit 702 is electrically coupled to the ultrasonictransmission waveguide 545 and the negative electrode RF(−) of theelectrical circuit 702 is electrically coupled to an electrode disposedin the jaw member 514, which is electrically coupled to the outer tube744. In operation, after tissue is grasped between the ultrasonic blade516 and the jaw member 514, control circuits of the surgical instrument500 can execute various algorithms to seal and the cut the tissue. Theultrasonic vibrations and high-frequency energy may be applied to thetissue in accordance with monitored tissue conditions such as tissueimpedance, friction, and the like. In some situations, high-frequencycurrent is applied to the tissue through the ultrasonic blade 516 andback to the outer tube 744 return path. The tissue impedance ismonitored and when a tissue seal is formed, as may be determined by thetissue impedance, the ultrasonic blade 516 is mechanically energized toinduce vibrational energy into the tissue to cut the tissue. In otheraspects ultrasonic vibrations and high-frequency may be applied bypulsing these energy modalities, applying the energy modalitiesalternatively or simultaneously. In somewhat unique situations, analgorithm can detect when the tissue impedance is extremely low todeliver energy to the tissue. In response, the algorithm energizes theultrasonic blade 516 mechanically to apply vibratory energy to thetissue until such time that the impedance rises above a thresholdsuitable for the application of the high-frequency current. Uponreaching this threshold, the algorithm switches energy delivery mode tohigh-frequency current to seal the tissue.

FIG. 34 is a schematic diagram of one aspect of an electrical circuit702 configured to drive a high-frequency current (RF), according to oneaspect of the present disclosure. The electrical circuit 702 comprisesan analog multiplexer 580. The analog multiplexer 580 multiplexesvarious signals from the upstream channels SCL-A/SDA-A such as RF,battery, and power control circuit. A current sensor 582 is coupled inseries with the return or ground leg of the power supply circuit tomeasure the current supplied by the power supply. A field effecttransistor (FET) temperature sensor 584 provides the ambienttemperature. A pulse width modulation (PWM) watchdog timer 588automatically generates a system reset if the main program neglects toperiodically service it. It is provided to automatically reset theelectrical circuit 702 when it hangs or freezes because of a software orhardware fault. It will be appreciated that the electrical circuit 702may be configured for driving RF electrodes or for driving theultrasonic transducer 130 as described in connection with FIG. 11, forexample. Accordingly, with reference now back to FIG. 34, the electricalcircuit 702 can be used to drive both ultrasonic and RF electrodesinterchangeably.

A drive circuit 586 provides left and right RF energy outputs. A digitalsignal that represents the signal waveform is provided to theSCL-A/SDA-A inputs of the analog multiplexer 580 from a control circuit,such as the control circuit 210 (FIG. 14). A digital-to-analog converter590 (DAC) converts the digital input to an analog output to drive a PWMcircuit 592 coupled to an oscillator 594. The PWM circuit 592 provides afirst signal to a first gate drive circuit 596 a coupled to a firsttransistor output stage 598 a to drive a first RF+ (Left) energy output.The PWM circuit 592 also provides a second signal to a second gate drivecircuit 596 b coupled to a second transistor output stage 598 b to drivea second RF− (Right) energy output. A voltage sensor 599 is coupledbetween the RF Left/RF output terminals to measure the output voltage.The drive circuit 586, the first and second drive circuits 596 a, 596 b,and the first and second transistor output stages 598 a, 598 b define afirst stage amplifier circuit. In operation, the control circuit 210(FIG. 14) generates a digital waveform 1800 (FIG. 67) employing circuitssuch as direct digital synthesis (DDS) circuits 1500, 1600 (FIGS. 65 and66). The DAC 590 receives the digital waveform 1800 and converts it intoan analog waveform, which is received and amplified by the first stageamplifier circuit.

FIG. 35 is a schematic diagram of the transformer 704 coupled to theelectrical circuit 702 shown in FIG. 34, according to one aspect of thepresent disclosure. The RF Left/RF input terminals (primary winding) ofthe transformer 704 are electrically coupled to the RF Left/RF outputterminals of the electrical circuit 702. One side of the secondarywinding is coupled in series with first and second blocking capacitors706, 708. The second blocking capacitor is coupled to the RF+ 574 aterminal. The other side of the secondary winding is coupled to the RF−574 b terminal. As previously discussed, the RF+ 574 a output is coupledto the ultrasonic blade 516 (FIG. 30) and the RF− 574 b ground terminalis coupled to the outer tube 544 (FIG. 30). In one aspect, thetransformer 166 has a turns-ratio of n1:n2 of 1:50.

FIG. 36 is a schematic diagram of a circuit 710 comprising separatepower sources for high power energy/drive circuits and low powercircuits, according to one aspect of the present disclosure. A powersupply 712 includes a primary battery pack comprising first and secondprimary batteries 715, 717 (e.g., Li-ion batteries) that are connectedinto the circuit 710 by a switch 718 and a secondary battery packcomprising a secondary battery 720 that is connected into the circuit bya switch 723 when the power supply 712 is inserted into the batteryassembly. The secondary battery 720 is a sag preventing battery that hascomponentry resistant to gamma or other radiation sterilization. Forinstance, a switch mode power supply 727 and optional charge circuitwithin the battery assembly can be incorporated to allow the secondarybattery 720 to reduce the voltage sag of the primary batteries 715, 717.This guarantees full charged cells at the beginning of a surgery thatare easy to introduce into the sterile field. The primary batteries 715,717 can be used to power the motor control circuits 726 and the energycircuits 732 directly. The power supply/battery pack 712 may comprise adual type battery assembly including primary Li-ion batteries 715, 717and secondary NiMH batteries 720 with dedicated energy cells 720 tocontrol the handle electronics circuits 730 from dedicated energy cells715, 717 to run the motor control circuits 726 and the energy circuits732. In this case the circuit 710 pulls from the secondary batteries 720involved in driving the handle electronics circuits 730 when the primarybatteries 715, 717 involved in driving the energy circuits 732 and/ormotor control circuits 726 are dropping low. In one various aspect, thecircuit 710 may include a one way diode that would not allow for currentto flow in the opposite direction (e.g., from the batteries involved indriving the energy and/or motor control circuits to the batteriesinvolved in driving the electronics circuits).

Additionally, a gamma friendly charge circuit may be provided thatincludes a switch mode power supply 727 using diodes and vacuum tubecomponents to minimize voltage sag at a predetermined level. With theinclusion of a minimum sag voltage that is a division of the NiMHvoltages (3 NiMH cells) the switch mode power supply 727 could beeliminated. Additionally a modular system may be provided wherein theradiation hardened components are located in a module, making the modulesterilizable by radiation sterilization. Other non-radiation hardenedcomponents may be included in other modular components and connectionsmade between the modular components such that the componentry operatestogether as if the components were located together on the same circuitboard. If only two NiMH cells are desired the switch mode power supply727 based on diodes and vacuum tubes allows for sterilizable electronicswithin the disposable primary battery pack.

Turning now to FIG. 37, there is shown a control circuit 800 foroperating a battery 801 powered RF generator circuit 802 for use withthe surgical instrument 500 shown in FIGS. 30 and 31, according to oneaspect of the present disclosure. The surgical instrument 500 isconfigured to use both ultrasonic vibration and high-frequency currentto carry out surgical coagulation/cutting treatments on living tissue,and uses high-frequency current to carry out a surgical coagulationtreatment on living tissue.

FIG. 37 illustrates a control circuit 800 that allows a dual generatorsystem to switch between the RF generator circuit 802 and the ultrasonicgenerator circuit 820 (similar to the electrical circuit 177 shown inFIGS. 11 and 12) energy modalities for the surgical instrument 500 shownin FIGS. 30 and 31. In one aspect, a current threshold in an RF signalis detected. When the impedance of the tissue is low the high-frequencycurrent through tissue is high when RF energy is used as the treatmentsource for the tissue. According to one aspect, a visual indicator 812or light located on the surgical instrument 500 may be configured to bein an on-state during this high current period. When the current fallsbelow a threshold, the visual indicator 812 is in an off-state.Accordingly, a photo-transistor 814 may be configured to detect thetransition from an on-state to an off-state and disengages the RF energyas shown in the control circuit 800 shown in FIG. 37. Therefore, whenthe energy button is released and the energy switch 826 is opened, thecontrol circuit 800 is reset and both the RF and ultrasonic generatorcircuits 802, 820 are held off.

With reference to FIGS. 30-33 and 37, in one aspect, a method ofmanaging an RF generator circuit 802 and ultrasound generator circuit820 is provided. As previously described the RF generator circuit 802and/or the ultrasound generator circuit 820 may be located in the handleassembly 502, the ultrasonic transducer/RF generator assembly 504, thebattery assembly 506, the shaft assembly 510, and/or the nozzle 700. Thecontrol circuit 800 is held in a reset state if the energy switch 826 isoff (e.g., open). Thus, when the energy switch 826 is opened, thecontrol circuit 800 is reset and both the RF and ultrasonic generatorcircuits 802, 820 are turned off. When the energy switch 826 is squeezedand the energy switch 826 is engaged (e.g., closed), RF energy isdelivered to the tissue and a visual indicator 812 operated by a currentsensing step-up transformer 804 will be lit while the tissue impedanceis low. The light from the visual indicator 812 provides a logic signalto keep the ultrasonic generator circuit 820 in the off state. Once thetissue impedance increases above a threshold and the high-frequencycurrent through the tissue decreases below a threshold, the visualindicator 812 turns off and the light transitions to an off-state. Alogic signal generated by this transition turns off the relay 808,whereby the RF generator circuit 802 is turned off and the ultrasonicgenerator circuit 820 is turned on, to complete the coagulation and cutcycle.

Still with reference to FIGS. 30-33 and 37, in one aspect, the dualgenerator circuit 802, 820 configuration employs an on-board RFgenerator circuit 802, which is battery 801 powered, for one modalityand a second, on-board ultrasound generator circuit 820, which may beon-board in the handle assembly 502, battery assembly 506, shaftassembly 510, nozzle 700, and/or the ultrasonic transducer/RF generatorassembly 504. The ultrasonic generator circuit 820 also is battery 801operated. In various aspects, the RF generator circuit 802 and theultrasonic generator circuit 820 may be an integrated or separablecomponent of the handle assembly 502. According to various aspects,having the dual RF/ultrasonic generator circuits 802, 820 as part of thehandle assembly 502 may eliminate the need for complicated wiring in anenvironment where the surgical instrument 500. The RF/ultrasonicgenerator circuits 802, 820 may be configured to provide the fullcapabilities of an existing generator while utilizing the capabilitiesof a cordless generator system simultaneously.

Either type of system can have separate controls for the modalities thatare not communicating with each other. The surgeon activates the RF andUltrasonic separately and at their discretion. Another approach would beto provide fully integrated communication schemes that share buttons,tissue status, instrument operating parameters (such as jaw closure,forces, etc.) and algorithms to manage tissue treatment. Variouscombinations of this integration can be implemented to provide theappropriate level of function and performance.

In one aspect, the control circuit 800 includes a battery 801 powered RFgenerator circuit 802 comprising a battery as an energy source. Asshown, RF generator circuit 802 is coupled to two electricallyconductive surfaces referred to herein as electrodes 806 a, 806 b and isconfigured to drive the electrodes 806 a, 806 b with RF energy (e.g.,high-frequency current). A first winding 810 a of a step-up transformer804 is connected in series with one pole of the bipolar RF generatorcircuit 802 and the return electrode 806 b. In one aspect, the firstwinding 810 a and the return electrode 806 b are connected to thenegative pole of the bipolar RF generator circuit 802. The other pole ofthe bipolar RF generator circuit 802 is connected to the activeelectrode 806 a through a switch contact 809 of a relay 808, or anysuitable electromagnetic switching device comprising an armature whichis moved by an electromagnet 836 to operate the switch contact 809. Theswitch contact 809 is closed when the electromagnet 836 is energized andthe switch contact 809 is open when the electromagnet 836 isde-energized. When the switch contact is closed, RF current flowsthrough conductive tissue (not shown) located between the electrodes 806a, 806 b. It will be appreciated, that in one aspect, the activeelectrode 806 a is connected to the positive pole of the bipolar RFgenerator circuit 802.

A visual indicator circuit 805 comprises a step-up transformer 804, aseries resistor R2, and a visual indicator 812. The visual indicator 812can be adapted for use with the surgical instrument 500 and otherelectrosurgical systems and tools, such as those described herein. Thefirst winding 810 a of the step-up transformer 804 is connected inseries with the return electrode 806 b and a second winding 810 b of thestep-up transformer 804 is connected in series with a resistor R2 and avisual indicator 812 comprising a type NE-2 neon bulb, for example.

In operation, when the switch contact 809 of the relay 808 is open, theactive electrode 806 a is disconnected from the positive pole of thebipolar RF generator circuit 802 and no current flows through thetissue, the return electrode 806 b, and the first winding 810 a of thestep-up transformer 804. Accordingly, the visual indicator 812 is notenergized and does not emit light. When the switch contact 809 of therelay 808 is closed, the active electrode 806 a is connected to thepositive pole of the bipolar RF generator circuit 802 enabling currentto flow through tissue, the return electrode 806 b, and the firstwinding 810 a of the step-up transformer 804 to operate on tissue, forexample cut and cauterize the tissue.

A first current flows through the first winding 810 a as a function ofthe impedance of the tissue located between the active and returnelectrodes 806 a, 806 b providing a first voltage across the firstwinding 810 a of the step-up transformer 804. A stepped up secondvoltage is induced across the second winding 810 b of the step-uptransformer 804. The secondary voltage appears across the resistor R2and energizes the visual indicator 812 causing the neon bulb to lightwhen the current through the tissue is greater than a predeterminedthreshold. It will be appreciated that the circuit and component valuesare illustrative and not limited thereto. When the switch contact 809 ofthe relay 808 is closed, current flows through the tissue and the visualindicator 812 is turned on.

Turning now to the energy switch 826 portion of the control circuit 800,when the energy switch 826 is open position, a logic high is applied tothe input of a first inverter 828 and a logic low is applied of one ofthe two inputs of the AND gate 832. Thus, the output of the AND gate 832is low and the transistor 834 is off to prevent current from flowingthrough the winding of the electromagnet 836. With the electromagnet 836in the de-energized state, the switch contact 809 of the relay 808remains open and prevents current from flowing through the electrodes806 a, 806 b. The logic low output of the first inverter 828 also isapplied to a second inverter 830 causing the output to go high andresetting a flip-flop 818 (e.g., a D-Type flip-flop). At which time, theQ output goes low to turn off the ultrasound generator circuit 820circuit and the Q output goes high and is applied to the other input ofthe AND gate 832.

When the user presses the energy switch 826 on the instrument handle toapply energy to the tissue between the electrodes 806 a, 806 b, theenergy switch 826 closes and applies a logic low at the input of thefirst inverter 828, which applies a logic high to other input of the ANDgate 832 causing the output of the AND gate 832 to go high and turns onthe transistor 834. In the on state, the transistor 834 conducts andsinks current through the winding of the electromagnet 836 to energizethe electromagnet 836 and close the switch contact 809 of the relay 808.As discussed above, when the switch contact 809 is closed, current canflow through the electrodes 806 a, 806 b and the first winding 810 a ofthe step-up transformer 804 when tissue is located between theelectrodes 806 a, 806 b.

As discussed above, the magnitude of the current flowing through theelectrodes 806 a, 806 b depends on the impedance of the tissue locatedbetween the electrodes 806 a, 806 b. Initially, the tissue impedance islow and the magnitude of the current high through the tissue and thefirst winding 810 a. Consequently, the voltage impressed on the secondwinding 810 b is high enough to turn on the visual indicator 812. Thelight emitted by the visual indicator 812 turns on the phototransistor814, which pulls the input of the inverter 816 low and causes the outputof the inverter 816 to go high. A high input applied to the CLK of theflip-flop 818 has no effect on the Q or the Q outputs of the flip-flop818 and Q output remains low and the Q output remains high. Accordingly,while the visual indicator 812 remains energized, the ultrasoundgenerator circuit 820 is turned OFF and the ultrasonic transducer 822and ultrasonic blade 824 are not activated.

As the tissue between the electrodes 806 a, 806 b dries up, due to theheat generated by the current flowing through the tissue, the impedanceof the tissue increases and the current therethrough decreases. When thecurrent through the first winding 810 a decreases, the voltage acrossthe second winding 810 b also decreases and when the voltage drops belowa minimum threshold required to operate the visual indicator 812, thevisual indicator 812 and the phototransistor 814 turn off. When thephototransistor 814 turns off, a logic high is applied to the input ofthe inverter 816 and a logic low is applied to the CLK input of theflip-flop 818 to clock a logic high to the Q output and a logic low tothe Q output. The logic high at the Q output turns on the ultrasoundgenerator circuit 820 to activate the ultrasonic transducer 822 and theultrasonic blade 824 to initiate cutting the tissue located between theelectrodes 806 a, 806 a. Simultaneously or near simultaneously with theultrasound generator circuit 820 turning on, the Q output of theflip-flop 818 goes low and causes the output of the AND gate 832 to golow and turn off the transistor 834, thereby de-energizing theelectromagnet 836 and opening the switch contact 809 of the relay 808 tocut off the flow of current through the electrodes 806 a, 806 b.

While the switch contact 809 of the relay 808 is open, no current flowsthrough the electrodes 806 a, 806 b, tissue, and the first winding 810 aof the step-up transformer 804. Therefore, no voltage is developedacross the second winding 810 b and no current flows through the visualindicator 812.

The state of the Q and the Q outputs of the flip-flop 818 remain thesame while the user squeezes the energy switch 826 on the instrumenthandle to maintain the energy switch 826 closed. Thus, the ultrasonicblade 824 remains activated and continues cutting the tissue between thejaws of the end effector while no current flows through the electrodes806 a, 806 b from the bipolar RF generator circuit 802. When the userreleases the energy switch 826 on the instrument handle, the energyswitch 826 opens and the output of the first inverter 828 goes low andthe output of the second inverter 830 goes high to reset the flip-flop818 causing the Q output to go low and turn off the ultrasound generatorcircuit 820. At the same time, the Q output goes high and the circuit isnow in an off state and ready for the user to actuate the energy switch826 on the instrument handle to close the energy switch 826, applycurrent to the tissue located between the electrodes 806 a, 806 b, andrepeat the cycle of applying RF energy to the tissue and ultrasonicenergy to the tissue as described above.

FIG. 38 is a sectional view of an end effector 900, according to oneaspect of the present disclosure. The end effector 900 comprises anultrasonic blade 902 and a jaw member 904. The jaw member 904 has achannel-shaped groove 906 in which part of the end effector 900 isengaged, along an axial direction. The channel-shaped groove 906 has awide channel shape with a wide opening in a section orthogonal to anaxis of the jaw member 904. The jaw member 904 is made of a conductivematerial, and an insulating member 910 is provided in a range where theultrasonic blade 902 is in contact along the axial direction on a bottomsurface portion 912 of the channel shape.

The ultrasonic blade 902 has a rhombic shape partially cut out in thesection orthogonal to the axial direction. The sectional shape of theultrasonic blade 902 is a shape which is cut out in the directionorthogonal to a longer diagonal line of the rhombic shape as shown inFIG. 38. The ultrasonic blade 902 with part of the rhombic shape cut outin the sectional shape has a trapezoidal portion 914 which is engaged inthe channel-shaped groove 906 of the jaw member 904. A portion in whichpart of the rhombic shape is not cut out in the sectional shape is anisosceles triangle portion 916 of the ultrasonic blade 902.

When the trigger of the handle assembly is closed, the ultrasonic blade902 and the jaw member 904 are fitted to each other. When they arefitted, the bottom surface portion 912 of the channel-shaped groove 906abuts on a top surface portion 918 of the trapezoidal portion 914 of theultrasonic blade 902, and two inner wall portions 920 of thechannel-shaped groove 906 abut on inclined surface portions 922 of thetrapezoidal portion 914.

Further, an apex portion 924 of the isosceles triangle portion 916 ofthe ultrasonic blade 902 is formed to be rounded, but the apex portion924 has a slightly sharp angle.

When the surgical instrument is used as a spatulate ultrasound treatmentinstrument, the ultrasonic blade 902 acts as an ultrasound vibrationtreatment portion, and the apex portion 924 and its peripheral portion(shown by the dotted line) particularly act as a scalpel knife to thetissue of the treatment object.

Further, when the surgical instrument is used as a spatulatehigh-frequency treatment instrument, the apex portion 924 and itsperipheral portion (shown by the dotted line) act as an electric scalpelknife to the tissue of the treatment object.

In one aspect, the bottom surface portion 912 and the inner wallportions 920, and the top surface portion 918 and the inclined surfaceportions 922 act as the working surfaces of an ultrasound vibration.

Further, in one aspect, the inner wall portions 920 and the inclinedsurface portions 922 act as the working surfaces of a bipolarhigh-frequency current.

In one aspect, the surgical instrument may be used as a spatulatetreatment instrument of simultaneous output of ultrasound andhigh-frequency current, the ultrasonic blade 902 acts as the ultrasoundvibration treatment portion, and the apex portion 924 and its peripheralportion (shown by the dotted line) particularly act as an electricalscalpel knife to the tissue of the treatment object.

Further, when the surgical instrument provides simultaneous output ofultrasound and high-frequency current, the bottom surface portion 912and the top surface portion 918 act as the working surfaces of anultrasound vibration, and the inner wall portions 920 and the inclinedsurface portions 922 act as the working surfaces of a bipolarhigh-frequency current.

Consequently, according to the configuration of the treatment portionshown in FIG. 37, excellent operability is provided not only in the caseof use of the surgical instrument as an ultrasound treatment instrumentor a high-frequency treatment instrument, but also in the case of use ofthe surgical instrument as an ultrasound treatment instrument orhigh-frequency current treatment instrument, and further in the case ofuse of the surgical instrument for the time of simultaneous output ofultrasound and high frequency.

When the surgical instrument performs high-frequency current output orsimultaneous output of high-frequency current and ultrasound, monopolaroutput may be enabled instead of a bipolar output as the high-frequencyoutput.

FIG. 39 is a sectional view of an end effector 930, according to oneaspect of the present disclosure. The jaw member 932 is made of aconductive material, and an insulating member 934 is provided along theaxial direction on a bottom surface portion 936 of the channel shape.

The ultrasonic blade 938 has a rhombic shape partially cut out in thesection orthogonal to the axial direction. The sectional shape of theultrasonic blade 938 is a shape in which part of the rhombic shape iscut out in the direction orthogonal to one diagonal line as shown inFIG. 39. The ultrasonic blade 938 with part of the rhombic shape cut outin the sectional shape has a trapezoidal portion 940 which is engaged ina channel-shaped groove 942 of the jaw member 932. A portion in whichpart of the rhombic shape is not cut out in the sectional shape is anisosceles triangle portion 944 of the end effector 900.

When the trigger of the handle assembly is closed, the ultrasonic blade938 and the jaw member 906 are fitted to each other. When they arefitted, the bottom surface portion 936 of the channel-shaped groove 942abuts on a top surface portion 946 of the trapezoidal portion 940 of theultrasonic blade 938, and two inner wall portions 954 of thechannel-shaped groove 932 abut on inclined surface portions 948 of thetrapezoidal portion 940.

Further, an apex portion 950 of the isosceles triangle portion 944 ofthe ultrasonic blade 938 is formed to be rounded, but an apex portion952 of the inner side of the hook shape has a slightly sharp angle. Anangle θ of the apex portion 952 is preferably 45° to 100°. 45° is astrength limit of the ultrasonic blade 938. As above, the apex portion952 of the ultrasonic blade 938 configures a protruding portion having apredetermined angle at the inner side of the hook-shaped portion, thatis, an edge portion.

The treatment portion in the hook shape is often used for dissection.The apex portion 952 of the end effector 930 becomes a working portionat the time of dissection. Since the apex portion 952 has the slightlysharp angle θ, the apex portion 952 is effective for dissectiontreatment.

The ultrasonic blade 938 and the jaw member 932 shown in FIG. 39 performthe same operation as the ultrasonic blade 938 and the jaw member 932shown in FIG. 38 at the time of ultrasound output, at the time ofhigh-frequency output, and at the time of simultaneous output ofultrasound and high frequency respectively, except for theaforementioned operation at the time of dissection.

Referring now to FIGS. 40-43, there is shown and end effector 1000operably coupled to an insertion sheath 1001, which is formed by anouter sheath 1002 and an inner sheath 1004. The end effector 1000comprises an ultrasonic blade 1006 and a jaw member 1014. In the outersheath 1002, the outside of a conductive metal pipe is covered with aninsulating resin tube. The inner sheath 1004 is a conductive metal pipe.The inner sheath 1004 can be axially moved back and forth relative tothe outer sheath 1002.

The ultrasonic blade 1006 is made of a conductive material having highacoustic effects and biocompatibility, for example, a titanium alloysuch as a Ti-6Al-4V alloy. In the ultrasonic blade 1006, an insulatingand elastic rubber lining 1008 is externally equipped in the position ofnodes of the ultrasonic vibration. The rubber lining 1008 is disposedbetween the inner sheath 1004 and the ultrasonic blade 1006 in acompressed state. The ultrasonic blade 1006 is held to the inner sheath1004 by the rubber lining 1008. A clearance is maintained between theinner sheath 1004 and the ultrasonic blade 1006.

An abutting portion 1010 is formed by the part of the ultrasonic blade1012 facing the jaw member 1014 at the distal end portion of theultrasonic blade 1006. Here, the ultrasonic blade 1012 is octagonal inits cross section perpendicular to the axial directions of theultrasonic blade 1006. An abutting surface 1016 is formed by one surfaceof the abutting portion 1010 facing the jaw member 1014. A pair ofelectrode surfaces 1018 is formed by surfaces provided to the sides ofthe abutting surface 1016.

The jaw member 1014 is formed by a body member 1020, an electrode member1022, a pad member 1024, and a regulating member 1026 as a regulatingsection.

The body member 1020 is made of a hard and conductive material. Aproximal end portion of the body member 1020 constitutes a pivotconnection portion 1028. The pivot connection portion 1028 is pivotallyconnected to a distal end portion of the outer sheath 1002 via a pivotconnection shaft 1030. The pivot connection shaft 1030 extends in widthdirections perpendicular to the axial directions and the opening/closingdirections. The body member 1020 can turn about the pivot connectionshaft 1030 in the opening/closing directions relative to the outersheath 1002. A distal end portion of the inner sheath 1004 is pivotallyconnected to the pivot connection portion 1028 of the body member 1020at a position provided to the distal side and the opening-direction sideof the pivot connection shaft 1030. If the movable handle is turnedrelative to the fixed handle in the handle unit, the inner sheath 1004is moved back and forth relative to the outer sheath 1002, and the bodymember 1020 is driven by the inner sheath 1004 to turn about the pivotconnection shaft 1030 in the opening/closing directions relative to theouter sheath 1002. In one aspect, a distal part of the body member 1020constitutes a pair of pivot bearings 1032. The pair of pivot bearings1032 are in the form of plates which extend in the axial directions andwhich are perpendicular to the width directions, and are disposed apartfrom each other in the width directions.

The electrode member 1022 is made of a hard and conductive material. Thepart of the electrode member 1022 provided on the opening-direction sideconstitutes a pivot support 1034. An insertion hole 1036 is formedthrough the pivot support 1034 in the width directions. A pivot supportshaft 1038 is inserted through the insertion hole 1036 and extends inthe width directions. The pivot support 1034 is disposed between thepair of pivot bearings 1032 of the body member 1020, and is pivotallysupported on the pair of pivot bearings 1032 via the pivot support shaft1038. The electrode member 1022 can oscillate about the pivot supportshaft 1038 relative to the body member 1020. Further, the part of theelectrode member 1022 provided on the closing-direction side constitutesan electrode section 1040. The electrode section 1040 extends in theaxial directions and projects to the sides in the width directions. Arecessed groove 1042 which is open toward the closing direction extendsin the axial directions in the part of the electrode section 1040provided on the closing-direction side. Teeth are axially provided inthe parts of the groove 1042 provided in the closing direction side,thus forming a tooth portion 1044. The side surfaces that define thegroove 1042 constitute a pair of electrode receiving surfaces 1046 thatare inclined from the closing direction toward the sides in the widthdirections. A recessed mating receptacle 1048 which is open toward theclosing direction axially extends in a bottom portion that defines thegroove 1042. An embedding hole 1050 is formed through the pivot support1034 of the electrode member 1022 in the opening/closing directionsperpendicularly to the insertion hole 1036. The embedding hole 1050 isopen to the mating receptacle 1048.

The pad member 1024 is softer than the ultrasonic blade 1006, and ismade of an insulating material having biocompatibility such aspolytetrafluorethylene. The pad member 1024 is mated with the matingreceptacle 1048 of the electrode member 1022. The part of the pad member1024 provided on the closing-direction side protrudes from the electrodemember 1022 to the closing direction, thus forming an abuttingreceptacle 1052. In the cross section perpendicular to the axialdirections, the abutting receptacle 1052 is in a recessed shapecorresponding to the projecting shape of the abutting portion 1010 ofthe ultrasonic blade 1012. When the jaw member 1014 is closed relativeto the ultrasonic blade 1012, the abutting portion 1010 of theultrasonic blade 1012 abuts onto and engages with the abuttingreceptacle 1052 of the pad member 1024. The pair of electrode surfaces1018 of the ultrasonic blade 1012 are arranged parallel to the pair ofelectrode receiving surfaces 1046 of the electrode section 1040, and aclearance is maintained between the electrode section 1040 and theultrasonic blade 1012.

The regulating member 1026 is harder than the ultrasonic blade 1006, andis made of an insulating high-strength material such as ceramics. Theregulating pad member 1024 is pin-shaped. The regulating pad member 1024is inserted into the embedding hole 1050 of the pivot support 1034 ofthe electrode member 1022, protrudes toward the mating receptacle 1048of the electrode section 1040, and is embedded in the abuttingreceptacle 1052 of the pad member 1024 in the mating receptacle 1048. Aclosing-direction end of the regulating member 1026 constitutes aregulating end 1054. The regulating end 1054 does not protrude from theabutting receptacle 1052 to the closing direction, and is accommodatedin the abutting receptacle 1052. The insertion hole 1036 is also formedthrough the regulating member 1026, and the pivot support shaft 1038 isinserted through the insertion hole 1036 of the regulating member 1026.

Here, the inner sheath 1004, the body member 1020, and the electrodemember 1022 are electrically connected to one another, and constitutethe first electrical path 1056 used in a high-frequency surgicaltreatment. The electrode section 1040 of the electrode member 1022functions as one of bipolar electrodes used in a high-frequency surgicaltreatment. In one aspect, the ultrasonic blade 1006 constitutes thesecond electrical path 1058 used in the high-frequency treatment. Theultrasonic blade 1012 provided to the distal end portion of theultrasonic blade 1006 functions as the other of the bipolar electrodesused in a high-frequency treatment. As described above, the ultrasonicblade 1006 is held to the inner sheath 1004 by the insulating rubberlining 1008, and the clearance is maintained between the inner sheath1004 and the ultrasonic blade 1006. This prevents a short circuitbetween the inner sheath 1004 and the ultrasonic blade 1006. When thejaw member 1014 is closed relative to the ultrasonic blade 1012, theabutting portion 1010 of the ultrasonic blade 1012 abuts onto andengages with the abutting receptacle 1052 of the pad member 1024. Thus,the pair of electrode surfaces 1018 of the ultrasonic blade 1012 arearranged parallel to the pair of electrode receiving surfaces 1046 ofthe electrode section 1040, and the clearance is maintained between theelectrode section 1040 and the ultrasonic blade 1012. This prevents ashort circuit between the electrode section 1040 and the ultrasonicblade 1012.

Referring to FIG. 44, the pad member 1024 is softer than the ultrasonicblade 1006. Therefore, the abutting receptacle 1052 is worn by theultrasonic blade 1012 in the case where the ultrasonic blade 1012 isultrasonically vibrated when the jaw member 1014 is closed relative tothe ultrasonic blade 1012 and the abutting portion 1010 of theultrasonic blade 1012 abuts onto and engages with the abuttingreceptacle 1052 of the pad member 1024. As the abutting receptacle 1052is worn, the clearance between the electrode section 1040 and theultrasonic blade 1012 is gradually reduced when the abutting portion1010 is in a frictional engagement with the abutting receptacle 1052.When the abutting receptacle 1052 is worn more than a predeterminedamount, the regulating end 1054 of the regulating member 1026 is exposedfrom the abutting receptacle 1052 in the closing direction. When theregulating end 1054 is exposed from the abutting receptacle 1052 in theclosing direction, the regulating end 1054 contacts the ultrasonic blade1012 before the electrode section 1040 contacts the ultrasonic blade1012 if the jaw member 1014 is closed relative to the ultrasonic blade1012. As a result, the contact between the ultrasonic blade 1012 and theelectrode section 1040 is regulated. Here, the electrode section 1040and the ultrasonic blade 1012 are hard. Therefore, when theultrasonically vibrated ultrasonic blade 1012 contacts the electrodesection 1040, the ultrasonic blade 1012 rapidly and repetitively comesin and out of contact with the electrode section 58. When ahigh-frequency voltage is applied between the electrode section 1040 andthe ultrasonic blade 1012, sparking occurs between the ultrasonic blade1012 and the electrode section 1040. In one aspect, the contact betweenthe ultrasonic blade 1012 and the electrode section 1040 is regulated bythe regulating end 1054 of the regulating member 1026, so that sparkingis prevented. The regulating member 1026 is made of an insulatingmaterial, and is electrically insulated relative to the electrode member1022. Thus, if the ultrasonically vibrated ultrasonic blade 1012contacts the regulating end 1054 of the regulating member 1026, nosparking occurs between the regulating end 1054 and the ultrasonic blade1012 even when the ultrasonic blade 1012 rapidly and repetitively comesin and out of contact with the regulating end 1054. This preventssparking between the ultrasonic blade 1012 and the jaw member 1014.

The regulating member 1026 is made of a high-strength material harderthan the ultrasonic blade 1006. Therefore, when the regulating end 1054contacts the ultrasonically vibrated ultrasonic blade 1012, theregulating member 1026 is not worn, and the ultrasonic blade 1006cracks. In the surgical treatment system according to one aspect, whenthe abutting receptacle 1052 is worn more than a predetermined amount,the regulating end 1054 contacts the ultrasonic blade 1012 tointentionally crack the ultrasonic blade 1006. By detecting this crack,the end of the life of the surgical treatment instrument is detected.Therefore, the position of the contact between the ultrasonic blade 1012and the regulating end 1054 is set at the stress concentration region inthe ultrasonic blade 1012 to ensure that the ultrasonic blade 1006cracks when the regulating end 1054 contacts the ultrasonic blade 1012.In a linear ultrasonic blade 1006, stress concentrates in the positionsof the nodes of the ultrasonic vibration, and a stress concentrationregion is located at the proximal end portion of the ultrasonic blade1012.

For a more detailed description of a combinationultrasonic/electrosurgical instrument, reference is made to U.S. Pat.No. 8,696,666 and U.S. Pat. No. 8,663,223, each of which is hereinincorporated by reference.

FIG. 45 illustrates a modular battery powered handheld electrosurgicalinstrument 1100 with distal articulation, according to one aspect of thepresent disclosure. The surgical instrument 1100 comprises having ahandle assembly 1102, a knife drive assembly 1104, a battery assembly1106, a shaft assembly 1110, and an end effector 1112. The end effector1112 comprises a pair of jaw members 1114 a, 1114 b in opposingrelationship affixed to a distal end thereof. The end effector 1112 isconfigured to articulate and rotate. FIG. 46 is an exploded view of thesurgical instrument 1100 shown in FIG. 45, according to one aspect ofthe present disclosure. The end effector 1112 for use with the surgicalinstrument 1100 for sealing and cutting tissue includes a pair of jawmembers 1114 a, 1114 b that in opposing relationship and movablerelative to each other to grasp tissue therebetween. A jaw member 1114a, 1114 b includes a jaw housing and an electrically conductive surface1116 a, 1116 b, e.g., electrodes, adapted to connect to a source ofelectrosurgical energy (RF source) such that the electrically conductivesurfaces are capable of conducting electrosurgical energy through tissueheld therebetween to effect a tissue seal. One of the electricallyconductive surfaces 1116 b includes a channel defined therein andextending along a length thereof that communicates with a drive rod 1145connected to a motor disposed in the knife drive assembly 1104. Theknife is configured to translate and reciprocate along the channel tocut tissue grasped between the jaw members 1114 a, 1114 b.

FIG. 47 is a perspective view of the surgical instrument 1100 shown inFIGS. 45 and 46 with a display located on the handle assembly 1102,according to one aspect of the present disclosure. The handle assembly1102 of the surgical instrument shown in FIGS. 45-47 comprises a motorassembly 1160 and a display assembly. The display assembly comprises adisplay 1176, such as an LCD display, for example, which is removablyconnectable to a housing 1148 portion of the handle assembly 1102. Thedisplay 1176 provides a visual display of surgical procedure parameterssuch as tissue thickness, status of seal, status of cut, tissuethickness, tissue impedance, algorithm being executed, battery capacity,among other parameters.

FIG. 48 is a perspective view of the instrument shown in FIGS. 45 and 46without a display located on the handle assembly 1102, according to oneaspect of the present disclosure. The handle assembly 1102 of thesurgical instrument 1150 shown in FIG. 48 includes a different displayassembly 1154 on a separate housing 1156. With reference now to FIGS.45-48, the surgical instrument 1100, 1150 is configured to usehigh-frequency (RF) current and a knife to carry out surgicalcoagulation/cutting treatments on living tissue, and uses high-frequencycurrent to carry out a surgical coagulation treatment on living tissue.The high-frequency (RF) current can be applied independently or incombination with algorithms or user input control. The display assembly,battery assembly 1106, and shaft assembly 1110 are modular componentsthat are removably connectable to the handle assembly 1102. A motor 1140is located within the handle assembly 1102. RF generator circuits andmotor drive circuits are described herein in connection with FIGS. 34-37and 50, for example, is located within the housing 1148.

The shaft assembly 1110 comprises an outer tube 1144, a knife drive rod1145, and an inner tube (not shown). The shaft assembly 1110 comprisesan articulation section 1130 and a distal rotation section 1134. The endeffector 1112 comprises jaw members 1114 a, 1114 b in opposingrelationship and a motor driven knife. The jaw member 1114 a, 1114 bcomprises an electrically conductive surface 1116 a, 1116 b coupled tothe RF generator circuit for delivering high-frequency current to tissuegrasped between the opposed jaw members 1114 a, 1114 b. The jaw members1114 a, 1114 b are pivotally rotatable about a pivot pin 1136 to grasptissue between the jaw members 1114 a, 1114 b. The jaw members 1114 a,1114 b are operably coupled to a trigger 1108 such that when the trigger1108 is squeezed the jaw members 1114 a, 1114 b close to grasp tissueand when the trigger 1108 is released the jaw members 1114 a, 1114 bopen to release tissue.

The jaw members 1114 a, 1114 b are operably coupled to a trigger 1108such that when the trigger 1108 is squeezed the jaw members 1114 a, 1114b close to grasp tissue and when the trigger 1108 is released the jawmembers 1114 a, 1114 b open to release tissue. In a one-stage triggerconfiguration, the trigger 1108 is squeezed to close the jaw members1114 a, 1114 b and, once the jaw members 1114 a, 1114 b are closed, afirst switch 1121 a of a switch section 1121 is activated to energizethe RF generator to seal the tissue. After the tissue is sealed, asecond switch 1121 b of the switch section 1120 is activated to advancea knife to cut the tissue. In various aspects, the trigger 1108 may be atwo-stage, or a multi-stage, trigger. In a two-stage triggerconfiguration, during the first stage, the trigger 1108 is squeezed partof the way to close the jaw members 1114 a, 1114 b and, during thesecond stage, the trigger 1108 is squeezed the rest of the way toenergize the RF generator circuit to seal the tissue. After the tissueis sealed, one of the first and second switches 1121 a, 1121 b can beactivated to advance the knife to cut the tissue. After the tissue iscut, the jaw members 1114 a, 1114 b are opened by releasing the trigger1108 to release the tissue. In another aspect, force sensors such asstrain gages or pressure sensors may be coupled to the trigger 1108 tomeasure the force applied to the trigger 1108 by the user. In anotheraspect, force sensors such as strain gages or pressure sensors may becoupled to the switch section 1120 first and second switch 1121 a, 1121b buttons such that displacement intensity corresponds to the forceapplied by the user to the switch section 1120 first and second switch1121 a, 1121 b buttons.

The battery assembly 1106 is electrically connected to the handleassembly 1102 by an electrical connector 1132. The handle assembly 1102is provided with a switch section 1120. A first switch 1121 a and asecond switch 1121 b are provided in the switch section 1120. The RFgenerator is energized by actuating the first switch 1121 a and theknife is activated by energizing the motor 1140 by actuating the secondswitch 1121 b. Accordingly, the first switch 1121 a energizes the RFcircuit to drive the high-frequency current through the tissue to form aseal and the second switch 1121 b energizes the motor to drive the knifeto cut the tissue. The structural and functional aspects of the batteryassembly 1106 are similar to those of the battery assembly 106 for thesurgical instrument 100 described in connection with FIGS. 1, 2, and16-24. Accordingly, for conciseness and clarity of disclosure, such thestructural and functional aspects of the battery assembly 106 areincorporated herein by reference and will not be repeated here.

A rotation knob 1118 is operably coupled to the shaft assembly 1110.Rotation of the rotation knob 1118 ±360° in the direction indicated bythe arrows 1126 causes the outer tube 1144 to rotate ±360° in therespective direction of the arrows 1119. In one aspect, another rotationknob 1122 may be configured to rotate the end effector 1112 ±360° in thedirection indicated by the arrows 1128 independently of the rotation ofthe outer tube 1144. The end effector 1112 may be articulated by way offirst and second control switches 1124 a, 1124 b such that actuation ofthe first control switch 1124 a articulates the end effector 1112 abouta pivot 1138 in the direction indicated by the arrow 1132 a andactuation of the second control switch 1124 b articulates the endeffector 1112 about the pivot 1138 in the direction indicated by thearrow 1132 b. Further, the outer tube 1144 may have a diameter D₃ranging from 5 mm to 10 mm, for example.

FIG. 49 is a motor assembly 1160 that can be used with the surgicalinstrument 1100, 1150 to drive the knife, according to one aspect of thepresent disclosure. The motor assembly 1160 comprises a motor 1162, aplanetary gear 1164, a shaft 1166, and a drive gear 1168. The gear maybe operably coupled to drive the knife bar 1145 (FIG. 46). In oneaspect, the drive gear 1168 or the shaft 1166 is operably coupled to arotary drive mechanism 1170 described in connection with FIG. 50 todrive distal head rotation, articulation, and jaw closure.

FIG. 50 is diagram of a motor drive circuit 1165, according to oneaspect of the present disclosure. The motor drive circuit 1165 issuitable for driving the motor M, which may be employed in the surgicalinstruments 1100, 1150 described herein. The motor M is driven by anH-bridge comprising four switches S₁-S₄. The switches S₁-S₄ aregenerally solid state switches such as MOSFET switches. To turn themotor M in one direction, two switches S₁, S₄ are turned on and theother two switches S₃, S₁ are turned off. To reverse the direction ofthe motor M, the state of the switches S₁-S₄ is reversed such that theswitches S₁, S₄ are turned off and the other two switches S₃, S₁ areturned on. Current sensing circuits can be placed in the motor drivecircuit 1165 to sense motor currents i_(1a), i_(2a), i_(1b), i_(2b).

FIG. 51 illustrates a rotary drive mechanism 1170 to drive distal headrotation, articulation, and jaw closure, according to one aspect of thepresent disclosure. The rotary drive mechanism 1170 has a primary rotarydrive shaft 1172 that is operably coupled to the motor assembly 1160.The primary rotary drive shaft 1172 is capable of being selectivelycoupled to at least two independent actuation mechanisms (first, second,both, neither) with a clutch mechanism located within the outer tube1144 of the shaft assembly 1110. The primary rotary drive shaft 1172 iscoupled to independent clutches that allow the shaft functions to beindependently coupled to the rotary drive shaft 1172. For example, thearticulation clutch 1174 is engaged to articulate the shaft assembly1110 about the articulation axis 1175 of the articulation section 1130.The distal head rotation clutch 1178 is engaged to rotate the distalrotation section 1134 and the jaw closure clutch 1179 is engaged toclose the jaw members 1114 a, 1114 b of the end effector 1112. The knifeis advanced and retracted by the knife drive rod 1145. All, none, or anycombination of rotary mechanisms can be couple at any one time.

In one aspect, a micro-electrical clutching configuration enablesrotation of the distal rotation section 1134 and articulation of thearticulation section 1130 about pivot 1138 and articulation axis 1175.In one aspect, a ferro-fluid clutch couples the clutch to the primaryrotary drive shaft 1172 via a fluid pump. The clutch ferro-fluid isactivated by electrical coils 1181, 1183, 1185 which are wrapped aroundthe knife drive rod 1145. The other ends of the coils 1181, 1183, 1185are connected to three separate control circuits to independentlyactuate the clutches 1174, 1178, 1179. In operation, when the coils1181, 1183, 1185 are not energized, the clutches 1174, 1178, 1179 aredisengaged and there is no articulation, rotation, or jaw movements.

When the articulation clutch 1174 is engaged by energizing the coil 1181and the distal head rotation clutch 1178 and the jaw closure clutch 1179are disengaged by de-energizing the coils 1183, 1185, a gear 1180 ismechanically coupled to the primary rotary drive shaft 1172 toarticulate the articulation section 1130. In the illustratedorientation, when the primary rotary drive shaft 1172 rotates clockwise,the gear 1180 rotates clockwise and the shaft articulates in the rightdirection about the articulation axis 1175 and when the primary rotarydrive shaft 1172 rotates counter clockwise, the gear 1180 rotatescounter clockwise and the shaft articulates in the left direction aboutthe articulation axis 1175. It will be appreciated that left/rightarticulation depends on the orientation of the surgical instrument 1100,1150.

When the articulation clutch 1174 and the jaw closure clutch 1179 aredisengaged by de-energizing the coils 1181, 1185, and the distal headrotation clutch 1178 is engaged by energizing the coil 1183, the primaryrotary drive shaft 1172 rotates the distal rotation section 1134 in thesame direction of rotation. When the coil 1183 is energized, the distalhead rotation clutch 1178 engages the primary rotary drive shaft 1172with the distal rotation section 1134. Accordingly, the distal rotationsection 1134 rotates with the primary rotary drive shaft 1172.

When the articulation clutch 1174 and the distal head rotation clutch1178 are disengaged by de-energizing the coils 1181, 1183, and the jawclosure clutch 1179 is engaged by energizing the coil 1185, the jawmembers 1114 a, 114 b can be opened or closed depending on the rotationof the primary rotary drive shaft 1172. When the coil 1185 is energized,the jaw closure clutch 1179 engages a captive inner threaded drivemember 1186, which rotates in place in the direction of the primaryrotary drive shaft 1172. The captive inner threaded drive member 1186includes outer threads that are in threaded engagement with an outerthreaded drive member 1188, which includes an inner threaded surface. Asthe primary rotary drive shaft 1172 rotates clockwise, the outerthreaded drive member 1188 that is in threaded engagement with thecaptive inner threaded drive member 1186 will be driven in a proximaldirection 1187 to close the jaw members 1114 a, 1114 b. As the primaryrotary drive shaft 1172 rotates counterclockwise, the outer threadeddrive member 1188 that is in threaded engagement with the captive innerthreaded drive member 1186 will be driven in a distal direction 1189 toopen the jaw members 1114 a, 1114 b.

FIG. 52 is an enlarged, left perspective view of an end effectorassembly with the jaw members shown in an open configuration, accordingto one aspect of the present disclosure. FIG. 53 is an enlarged, rightside view of the end effector assembly of FIG. 52, according to oneaspect of the present disclosure. Referring now to FIGS. 52 and 53,enlarged views of an end effector 1112 shown in an open position forapproximating tissue. Jaw members 1114, 1114 b are generally symmetricaland include similar component features which cooperate to permit facilerotation about pivot pin 1136 to effect the sealing and dividing oftissue. As a result and unless otherwise noted, only the jaw member 1114a and the operative features associated therewith are describe in detailherein but as can be appreciated, many of these features apply to theother jaw member 1114 b as well.

The jaw member 1114 a also includes a jaw housing 1115 a, an insulativesubstrate or insulator 1117 a and an electrically conductive surface1116 a. The insulator 1117 a is configured to securely engage theelectrically conductive sealing surface 1116 a. This may be accomplishedby stamping, by overmolding, by overmolding a stamped electricallyconductive sealing plate and/or by overmolding a metal injection moldedseal plate. These manufacturing techniques produce an electrode havingan electrically conductive surface 1116 a that is surrounded by aninsulator 1117 a.

As mentioned above, the jaw member 1114 a includes similar elementswhich include: a jaw housing 1115 b; insulator 1117 b; and anelectrically conductive surface 1116 b that is dimensioned to securelyengage the insulator 1117 b. Electrically conductive surface 1116 b andthe insulator 1117 b, when assembled, form a longitudinally-orientedknife channel 1113 defined therethrough for reciprocation of the knifeblade 1123. The knife channel 1113 facilitates longitudinalreciprocation of the knife blade 1123 along a predetermined cuttingplane to effectively and accurately separate the tissue along the formedtissue seal. Although not shown, the jaw member 1114 a may also includea knife channel that cooperates with the knife channel 1113 tofacilitate translation of the knife through tissue.

The jaw members 1114 a, 1114 b are electrically isolated from oneanother such that electrosurgical energy can be effectively transferredthrough the tissue to form a tissue seal. The electrically conductivesurfaces 1116 a, 1116 b are also insolated from the remaining operativecomponents of the end effector 1112 and the outer tube 1144. A pluralityof stop members may be employed to regulate the gap distance between theelectrically conductive surfaces 1116 a, 1116 b to insure accurate,consistent, and reliable tissue seals.

The structural and functional aspects of the battery assembly 1106 aresimilar to those of the battery assembly 106 for the surgical instrument100 described in connection with FIGS. 1, 2, and 16-24, including thebattery circuits described in connection with FIGS. 20-24. Accordingly,for conciseness and clarity of disclosure, such the structural andfunctional aspects of the battery assembly 106 are incorporated hereinby reference and will not be repeated here. Furthermore, the structuraland functional aspects of the RF generator circuits are similar to thoseof the RF generator circuits described in for the surgical instruments500, 600 described in connection with FIGS. 34-37. Accordingly, forconciseness and clarity of disclosure, such the structural andfunctional aspects of the RF generator circuits are incorporated hereinby reference and will not be repeated here. Furthermore, the surgicalinstrument 1100 includes the battery and control circuits described inconnection with FIGS. 12-15, including, for example, the control circuit210 described in connection with FIG. 14 and the electrical circuit 300described in connection with FIG. 15. Accordingly, for conciseness andclarity of disclosure, the description of the circuits described inconnection with FIGS. 12-15 is incorporated herein by reference and willnot be repeated here.

For a more detailed description of an electrosurgical instrumentcomprising a cutting mechanism and an articulation section that isoperable to deflect the end effector away from the longitudinal axis ofthe shaft, reference is made to U.S. Pat. Nos. 9,028,478 and 9,113,907,each of which is herein incorporated by reference.

FIG. 54 illustrates a modular battery powered handheld electrosurgicalinstrument 1200 with distal articulation, according to one aspect of thepresent disclosure. The surgical instrument 1200 comprises a handleassembly 1202, a knife drive assembly 1204, a battery assembly 1206, ashaft assembly 1210, and an end effector 1212. The end effector 1212comprises a pair of jaw members 1214 a, 1214 b in opposing relationshipaffixed to a distal end thereof. The end effector 1212 is configured toarticulate and rotate. FIG. 55 is an exploded view of the surgicalinstrument 1200 shown in FIG. 54, according to one aspect of the presentdisclosure. The end effector 1212 for use with the surgical instrument1200 for sealing and cutting tissue includes a pair of jaw members 1214a, 1214 b in opposing relationship movable relative to each other tograsp tissue therebetween. Either jaw member 1214 a, 1214 b may includea jaw housing and an electrically conductive surface 1216 a, 1216 b,e.g., electrodes, adapted to connect to a source of electrosurgicalenergy (RF source) such that the electrically conductive surfaces arecapable of conducting electrosurgical energy through tissue heldtherebetween to effect a tissue seal. The jaw members 1214 a, 1214 b andthe electrically conductive surfaces 1216 a, 1216 b include a channeldefined therein and extending along a length thereof that communicateswith a knife drive rod 1245 connected to a knife drive assembly 1204.The knife 1274 (FIGS. 60-61) is configured to translate and reciprocatealong the channels to cut tissue grasped between the jaw members 1214 a,1214 b. The knife has an I-beam configuration such that the jaw members1214 a, 1214 b are brought closer together as the knife 1274 advancesthrough the channels. In one aspect, the electrically conductivesurfaces 1216 a, 1216 b are offset relative to each other. The knife1274 includes a sharp distal end.

The handle assembly 1202 of the surgical instrument shown in FIGS. 54-55comprises a motor assembly 1260 and a knife drive assembly 1204. In oneaspect, a display assembly may be provided on the housing 1248. Thedisplay assembly may comprise a display, such as an LCD display, forexample, which is removably connectable to a housing 1248 portion of thehandle assembly 1202. The LCD display provides a visual display ofsurgical procedure parameters such as tissue thickness, status of seal,status of cut, tissue thickness, tissue impedance, algorithm beingexecuted, battery capacity, among other parameters. With reference nowto FIGS. 54-55, the surgical instrument 1200 is configured to usehigh-frequency (RF) current and a knife 1274 (FIGS. 60-61) to carry outsurgical coagulation/cutting treatments on living tissue, and useshigh-frequency current to carry out a surgical coagulation treatment onliving tissue. The high-frequency (RF) current can be appliedindependently or in combination with algorithms or user input control.The knife drive assembly 1204, battery assembly 1206, and shaft assembly1210 are modular components that are removably connectable to the handleassembly 1202. A motor assembly 1240 may be located within the handleassembly 1202. The RF generator and motor drive circuits are describedin connection with FIGS. 34-37 and 50, for example, are located withinthe housing 1248. The housing 1248 includes a removable cover plate 1276to provide access to the circuits and mechanisms located within thehousing 1248. The knife drive assembly 1204 includes gears and linkagesoperably coupled to the handle assembly 1202 and the switch section 1220to activate and drive the knife 1274. As discussed in more detailhereinbelow, the knife 1274 has an I-beam configuration.

The shaft assembly 1210 comprises an outer tube 1244, a knife drive rod1245, and an inner tube (not shown). The shaft assembly 1210 comprisesan articulation section 1230. The end effector 1212 comprises a pair ofjaw members 1214 a, 1214 b and a knife 1274 configured to reciprocatewith channels formed in the jaw members 1214 a, 1214 b. In one aspect,the knife 1274 may be driven by a motor. The jaw member 1214 a, 1214 bcomprises an electrically conductive surface 1216 a, 1216 b coupled tothe RF generator circuit for delivering high-frequency current to tissuegrasped between the jaw members 1214 a, 1214 b. The jaw members 1214 a,1214 b are pivotally rotatable about a pivot pin 1235 to grasp tissuebetween the jaw members 1214 a, 1214 b. The jaw members 1214 a, 1214 bare operably coupled to a trigger 1208 such that when the trigger 1208is squeezed one or both of the jaw members 1214 a, 1214 b close to grasptissue and when the trigger 1208 is released the jaw members 1214 a,1214 b open to release tissue. In the illustrated example, one jawmember 1214 a is movable relative to the other jaw member 1214 b. Inother aspects, both jaw members 1214 a, 1214 b may be movable relativeto each other. In another aspect, force sensors such as strain gages orpressure sensors may be coupled to the trigger 1208 to measure the forceapplied to the trigger 1208 by the user. In another aspect, forcesensors such as strain gages or pressure sensors may be coupled to theswitch section 1220 first and second switch 1221 a, 1221 b buttons suchthat displacement intensity corresponds to the force applied by the userto the switch section 1220 first and second switch 1221 a, 1221 bbuttons.

The jaw member 1214 a is operably coupled to a trigger 1208 such thatwhen the trigger 1208 is squeezed the jaw member 1214 a closes to grasptissue and when the trigger 1208 is released the jaw member 1214 a opensto release tissue. In a one-stage trigger configuration, the trigger1208 is squeezed to close the jaw member 1214 a and, once the jaw member1214 a is closed, a first switch 1221 a of a switch section 1220 isactivated to energize the RF generator to seal the tissue. After thetissue is sealed, a second switch 1221 b of the switch section 1220 isactivated to advance a knife to cut the tissue. In various aspects, thetrigger 1208 may be a two-stage, or a multi-stage, trigger. In atwo-stage trigger configuration, during the first stage, the trigger1208 is squeezed part of the way to close the jaw member 1214 a andduring the second stage, the trigger 1208 is squeezed the rest of theway to energize the RF generator circuit to seal the tissue. After thetissue is sealed, one of the switches 1221 a, 1221 b can be activated toadvance the knife to cut the tissue. After the tissue is cut, the jawmember 1214 a is opened by releasing the trigger 1208 to release thetissue.

The shaft assembly 1210 includes an articulation section 1230 that isoperable to deflect the end effector 1212 away from the longitudinalaxis “A” of the shaft assembly 1210. The dials 1232 a, 1232 b areoperable to pivot the articulation section 1230 at the distal end of theelongated shaft assembly 1210 to various articulated orientations withrespect to the longitudinal axis A-A. More particularly, thearticulation dials 1232 a, 1232 b operably couple to a plurality ofcables or tendons that are in operative communication with thearticulation section 1230 of the shaft assembly 1210, as described ingreater detail below. One articulation dial 1232 a may be rotated in thedirection of arrows “C0” to induce pivotal movement in a first plane,e.g., a vertical plane, as indicated by arrows “C1”. Similarly, anotherarticulation dial 1232 b may be rotated in the direction of arrows “D0”to induce pivotal movement in a second plane, e.g., a horizontal plane,as indicated by arrows “D1”. Rotation of the articulation dials 1232 a,1232 b in either direction of arrows “C0” or “D0” results in the tendonspivoting or articulating the shaft assembly 1210 about the articulationsection 1230.

The battery assembly 1206 is electrically connected to the handleassembly 1202 by an electrical connector 1231. The handle assembly 1202is provided with a switch section 1220. A first switch 1221 a and asecond switch 1221 b are provided in the switch section 1220. The RFgenerator is energized by actuating the first switch 1221 a and theknife 1274 may be activated by energizing the motor assembly 1240 byactuating the second switch 1221 b. Accordingly, the first switch 1221 aenergizes the RF circuit to drive the high-frequency current through thetissue to form a seal and the second switch 1221 b energizes the motorto drive the knife 1274 to cut the tissue. In other aspects, the knife1274 may be fired manually using a two-stage trigger 1208 configuration.The structural and functional aspects of the battery assembly 1206 aresimilar to those of the battery assembly 106 for the surgical instrument100 described in connection with FIGS. 1, 2, and 16-24. Accordingly, forconciseness and clarity of disclosure, such the structural andfunctional aspects of the battery assembly 106 are incorporated hereinby reference and will not be repeated here.

A rotation knob 1218 is operably coupled to the shaft assembly 1210.Rotation of the rotation knob 1218 ±360° in the direction indicated bythe arrows 1226 causes the outer tube 1244 to rotate ±360° in therespective direction of the arrows 1228. The end effector 1212 may bearticulated by way of control buttons such that actuation of controlbuttons articulates the end effector 1212 in one direction indicated byarrows C1 and D1. Further, the outer tube 1244 may have a diameter D₃ranging from 5 mm to 10 mm, for example.

FIG. 56 is an enlarged area detail view of an articulation sectionillustrated in FIG. 54 including electrical connections, according toone aspect of the present disclosure. FIG. 57 is an enlarged area detailview articulation section illustrated in FIG. 56 including electricalconnections, according to one aspect of the present disclosure. Withreference now to FIGS. 56-57, there is shown the articulation section1230 is operably disposed on or coupled to the shaft assembly 1210between the proximal end and the distal end 1222, respectively. In theaspect illustrated in FIGS. 56-57, the articulation section 1230 isdefined by a plurality of articulating links 1233 (links 1233). Thelinks 1233 are configured to articulate the shaft assembly 1210transversely across the longitudinal axis “A-A” in either a horizontalor vertical plane, see FIG. 54. For illustrative purposes, the shaftassembly 1210 is shown articulated across the horizontal plane.

The links 1233 collectively define a central annulus 1238 therethroughthat is configured to receive a drive mechanism, e.g., a drive rod,therethrough. As can be appreciated, the configuration of the centralannulus 1238 provides adequate clearance for the drive rod therethrough.The central annulus 1238 defines an axis “B-B” therethrough that isparallel to the longitudinal axis “A-A” when the shaft assembly 1210 isin a non-articulated configuration, see FIG. 54.

Continuing with reference to FIGS. 56-57, the links 1233 are operablycoupled to the articulation dials 1232 a, 1232 b via tendons 1234. Forillustrative purposes, four (4) tendons 1234 are shown. The tendons 1234may be constructed of stainless steel wire or other material suitablefor transmitting tensile forces to a distal-most link of links 1233.Regardless of the construction materials, the tendons 1234 exhibit aspring rate that is amplified over the length of the tendons 1234 andthus, the tendons 1234 may tend to stretch when external loads areapplied to the elongated shaft assembly 1210. This tendency to stretchmay be associated with an unintended change in orientation of the distalend 1222 of the elongated shaft assembly 1210, e.g., without acorresponding movement of the articulation dials 1232 a, 1232 binitiated by the surgeon.

The tendons 1234 operably couple to the articulating dials 1232 a, 1232b that are configured to actuate the tendons 1234, e.g., “pull” thetendons 1234, when the articulating dials 1232 a, 1232 b are rotated.The plurality of tendons 1234 operably couple to the links 1233 via oneor more suitable coupling methods. More particularly, the link 1233includes a corresponding plurality of first apertures or bores 1236 adefined therein (four (4) bores 1236 a are shown in the representativefigures) that are radially disposed along the links 1233 and centrallyaligned along a common axis, see FIG. 56. A bore of the plurality ofbores 1236 a is configured to receive a tendon 1234. A distal end of atendon 1234 is operably coupled to a distal most link of the links 1233by suitable methods, e.g., one or more of the coupling methods describedabove.

Continuing with reference to FIGS. 56-57 a link 1233 includes a secondplurality of bores 1236 b (four (4) bores 1236 b are shown in therepresentative drawings, as best seen in FIG. 56). A bore 1236 b isconfigured to receive a corresponding conductive lead of a plurality ofconductive leads 1237 (four (4) conductive leads 1237 are shown in therepresentative drawings). The conductive leads 1237 are configured totransition between first and second states within the second pluralityof bores 1236 b. To facilitate transitioning of the conductive leads1237, a bore 1236 b includes a diameter that is greater than a diameterof the conductive leads 1237 when the conductive leads 1237 are in thefirst state.

The surgical instrument 1220 includes electrical circuitry that isconfigured to selectively induce a voltage and current flow to theplurality of conductive leads 1237 such that a conductive lead 1237transitions from the first state to the second state. To this end, thegenerator G provides a voltage potential Eo of suitable proportion. Avoltage is induced in a conductive lead 1237 and current flowtherethrough. The current flowing through a conductive lead 1237 causesthe conductive lead 1237 to transition from the first state (FIG. 56) tothe second state (FIG. 57). In the second state, the conductive lead1237 provides an interference fit between the conductive lead 1237 andthe corresponding bores 1236 b, as best seen in FIG. 57.

FIG. 58 illustrates a perspective view of components of the shaftassembly 1210, end effector 1212, and cutting member 1254 of thesurgical instrument 1200 of FIG. 54, according to one aspect of thepresent disclosure. FIG. 59 illustrates the articulation section in asecond stage of articulation, according to one aspect of the presentdisclosure. With reference now to FIGS. 58-59, one articulation band1256 a is slidably disposed in one side recess of a separator 1261 whilea second articulation band 1256 b (FIG. 59) is slidably disposed in theother side recess of the separator 1261. A cutting member driver tube ismovable longitudinally to drive a driver block 1258 longitudinally, tothereby move cutting member 1254 longitudinally. The side recessesinclude longitudinally extending grooves that are configured to reducethe contact surface area with articulation bands 1256 a, 1256 b, therebyreducing friction between separator 1261 and articulation bands 1256 a,1256 b. The separator 1261 also may be formed of a low friction materialand/or include a surface treatment to reduce friction. Articulationbands 1256 a, 1256 b extend longitudinally along the length of the shaftassembly 1210, including through the articulation section 1230. Thedistal end 1252 of one articulation band 1256 a is secured to one sideof the proximal portion 1250 of end effector 1212 at an anchor point.The distal end 1262 of the second articulation band 1256 b is secured tothe other side of proximal portion 1250 of end effector 1212 at ananchor point. A rotary articulation knob is operable to selectivelyadvance the articulation band 1256 a distally while simultaneouslyretracting the second articulation band 1256 b proximally, andvice-versa. It should be understood that this opposing translation willcause articulation section 1230 to bend, thereby articulating endeffector 1212. In particular, the end effector 1212 will deflect towardwhichever articulation band 1256 a, 1256 b is being retractedproximally; and away from whichever articulation band 1256 a, 1256 b isbeing advanced distally.

With continued referenced to FIGS. 58-59, several of the above describedcomponents are shown interacting to bend the articulation section 1230to articulate end effector 1212. In FIG. 58, articulation 1230 is in astraight configuration. Then, one of the articulation dials 1232 a, 1232b (FIGS. 54-55) is rotated, which causes a lead screw to translateproximally and another lead screw to advance distally. This proximaltranslation of one lead screw pulls the articulation band 1256 bproximally, which causes articulation section 1230 to start bending asshown in FIG. 59. This bending of articulation section 1230 pulls theother articulation band 1256 a distally. The distal advancement of leadscrew in response to rotation of the articulation dials 1232 a, 1232 benables the articulation band 1256 a and the drive member to advancedistally. In some other versions, the distal advancement of the leadscrew actively drives drive member and articulation band 1256 adistally. As the user continues rotating one of the articulation dials1232 a, 1232 b, the above described interactions continue in the samefashion, resulting in further bending of articulation section 1230 asshown in FIG. 59. It should be understand that rotating the articulationdials 1232 a, 1232 b in the opposite direction will cause articulationsection 1230 to straighten, and further rotation in the oppositedirection will cause articulation section 1230 to bend in the oppositedirection.

FIG. 60 illustrates a perspective view of the end effector 1212 of thedevice of FIGS. 54-59 in an open configuration, according to one aspectof the present disclosure. The end effector 1212 of the present examplecomprises a pair of jaw members 1214 a, 1214 b. In the present example,one jaw member 1214 b is fixed relative to shaft assembly; while theother jaw member 1214 a pivots relative to shaft assembly, toward andaway from the other jaw member 1214 b. In some versions, actuators suchas rods or cables, etc., may extend through a sheath and be joined withone jaw member 1214 a at a pivotal coupling, such that longitudinalmovement of the actuator rods/cables/etc. through the shaft assemblyprovides pivoting of the jaw member 1214 a relative to shaft assemblyand relative to the second jaw member 1214 b. Of course, the jaw members1214 a, 1214 b instead may have any other suitable kind of movement andmay be actuated in any other suitable fashion. By way of example only,the jaw members 1214 a, 1214 b may be actuated and thus closed bylongitudinal translation of a firing beam 1266, such that actuatorrods/cables/etc. may simply be eliminated in some versions. The upperside of one jaw member 1214 a including a plurality of teeth serrations1272. It should be understood that the lower side of the other jawmember 1214 b may include complementary serrations 1277 that nest withthe serrations 1272, to enhance gripping of tissue captured between thejaw members 1214 a, 1214 b of the end effector 1212 without necessarilytearing the tissue.

FIG. 61 illustrates a cross-sectional end view of the end effector 1212of FIG. 60 in a closed configuration and with the blade 1274 in a distalposition, according to one aspect to the present disclosure. Withreference now to FIGS. 60-61, one jaw member 1214 a defines alongitudinally extending elongate slot 1268; while the other jaw member1214 b also defines a longitudinally extending elongate slot 1270. Inaddition, the underside of one jaw member 1214 a presents anelectrically conductive surface 1216 a; while the top side of the otherjaw member 1214 b presents another electrically conductive surface 1216b. The electrically conductive surfaces 1216 a, 1216 b are incommunication with an electrical source 1278 and a controller 1280 viaone or more conductors (not shown) that extend along the length of shaftassembly. The electrical source 1278 is operable to deliver RF energy tofirst electrically conductive surface 1216 b at a first polarity and tosecond electrically conductive surface 1216 a at a second (opposite)polarity, such that RF current flows between electrically conductivesurfaces 1216 a, 1216 b and thereby through tissue captured between thejaw members 1214 a, 1214 b. In some versions, firing beam 1266 serves asan electrical conductor that cooperates with the electrically conductivesurfaces 1216 a, 1216 b (e.g., as a ground return) for delivery ofbipolar RF energy captured between the jaw members 1214 a, 1214 b. Theelectrical source 1278 may be external to surgical instrument 1200 ormay be integral with surgical instrument 1200 (e.g., in the handleassembly 1202, etc.), as described in one or more references citedherein or otherwise. A controller 1280 regulates delivery of power fromelectrical source 1278 to the electrically conductive surfaces 1216 a,1216 b. The controller 1280 may also be external to surgical instrument1200 or may be integral with surgical instrument 1200 (e.g., in handleassembly 1202, etc.), as described in one or more references citedherein or otherwise. It should also be understood that the electricallyconductive surfaces 1216 a, 1216 b may be provided in a variety ofalternative locations, configurations, and relationships.

Still with reference to FIGS. 60-61, the surgical instrument 1200 of thepresent example includes a firing beam 1266 that is longitudinallymovable along part of the length of end effector 1212. The firing beam1266 is coaxially positioned within the shaft assembly 1210, extendsalong the length of the shaft assembly 1210, and translateslongitudinally within the shaft assembly 1210 (including thearticulation section 1230 in the present example), though it should beunderstood that firing beam 12660 and the shaft assembly 1210 may haveany other suitable relationship. The firing beam 1266 includes a knife1274 with a sharp distal end, an upper flange 1281, and a lower flange1282. As best seen in FIG. 61, the knife 1274 extends through slots1268, 1270 of the jaw members 1214 a, 1214 b, with the upper flange 1281being located above the jaw member 1214 a in a recess 1284 and the lowerflange 1282 being located below the jaw member 1214 b in a recess 1286.The configuration of the knife 1274 and the flanges 1281, 1282 providesan “I-beam” type of cross section at the distal end of firing beam 1266.While the flanges 1281, 1282 extend longitudinally only along a smallportion of the length of firing beam 1266 in the present example, itshould be understood that the flanges 1281, 1282 may extendlongitudinally along any suitable length of firing beam 1266. Inaddition, while the flanges 1281, 1282 are positioned along the exteriorof the jaw members 1214 a, 1214 b, the flanges 1281, 1282 mayalternatively be disposed in corresponding slots formed within jawmembers 1214 a, 1214 b. For instance, the jaw members 1214 a, 1214 b maydefine a “T”-shaped slot, with parts of the knife 1274 being disposed inone vertical portion of a “T”-shaped slot and with the flanges 1281,1282 being disposed in the horizontal portions of the “T”-shaped slots.Various other suitable configurations and relationships will be apparentto those of ordinary skill in the art in view of the teachings herein.By way of example only, the end effector 1212 may include one or morepositive temperature coefficient (PTC) thermistor bodies 1288, 1290(e.g., PTC polymer, etc.), located adjacent to the electricallyconductive surfaces 1216 a, 1216 b and/or elsewhere.

The structural and functional aspects of the battery assembly 1206 aresimilar to those of the battery assembly 106 for the surgical instrument100 described in connection with FIGS. 1, 2, and 16-24, including thebattery circuits described in connection with FIGS. 20-24. Accordingly,for conciseness and clarity of disclosure, such the structural andfunctional aspects of the battery assembly 106 are incorporated hereinby reference and will not be repeated here. Furthermore, the structuraland functional aspects of the RF generator circuits are similar to thoseof the RF generator circuits described in for the surgical instruments500, 600 described in connection with FIGS. 34-37. Accordingly, forconciseness and clarity of disclosure, such the structural andfunctional aspects of the RF generator circuits are incorporated hereinby reference and will not be repeated here. Furthermore, the surgicalinstrument 1200 includes the battery and control circuits described inconnection with FIGS. 12-15, including, for example, the control circuit210 described in connection with FIG. 14 and the electrical circuit 300described in connection with FIG. 15. Accordingly, for conciseness andclarity of disclosure, the description of the circuits described inconnection with FIGS. 12-15 is incorporated herein by reference and willnot be repeated here.

For a more detailed description of an electrosurgical instrumentcomprising a cutting mechanism and an articulation section that isoperable to deflect the end effector away from the longitudinal axis ofthe shaft, reference is made to U.S. Pub. No. 2013/0023868, which isherein incorporated by reference.

It should also be understood that any of the surgical instruments 100,480, 500, 600, 1100, 1150, 1200 described herein may be modified toinclude a motor or other electrically powered device to drive anotherwise manually moved component. Various examples of suchmodifications are described in U.S. Pub. No. 2012/0116379 and U.S. Pub.No. 2016/0256184, each of which is incorporated herein by reference.Various other suitable ways in which a motor or other electricallypowered device may be incorporated into any of the devices herein willbe apparent to those of ordinary skill in the art in view of theteachings herein.

It should also be understood that the circuits described in connectionwith FIGS. 11-15, 20-24, 34-37, and 50 may be configured to operateeither alone or in combination with any of the surgical instruments 100,480, 500, 600, 1100, 1150, 1200 described herein.

FIGS. 62-70 describe various circuits that are configured to operatewith any one of the surgical instruments 100, 480, 500, 600, 1100, 1150,1200 described in connections with FIGS. 1-61. Turning now to FIG. 62,there is shown the components of a control circuit 1300 of the surgicalinstrument, according to one aspect of the present disclosure. Thecontrol circuit 1300 comprises a processor 1302 coupled to a volatilememory 1304, one or more sensors 1306, a nonvolatile memory 1308 and abattery 1310. In one aspect, the surgical instrument may comprise ahandle housing to house the control circuit 1300 and to contain generalpurpose controls to implement the power conservation mode. In someaspects, the processor 1302 may be a primary processor of the surgicalinstrument that includes one or more secondary processors. In someaspects, the processor 1302 may be stored within the battery 1310. Theprocessor 1302 is configured to control various operations and functionsof the surgical instrument by executing machine executable instructions,such as control programs or other software modules. For example,execution of an energy modality control program by the processor 1302enables selection of a particular type of energy to be applied topatient tissue by a surgeon using the surgical instrument. The surgicalinstrument may comprise an energy modality actuator located on thehandle of the surgical instrument. The actuator may be a slider, atoggle switch, a segmented momentary contact switch, or some other typeof actuator. Actuation of the energy modality actuator causes theprocessor 1302 to activate an energy modality corresponding to aselected type of energy. The type of energy can be ultrasonic, RF, or acombination of ultrasonic and RF energy. In various aspects general, theprocessor 1302 is electrically coupled to the plurality of circuitsegments of the surgical instrument as illustrated in FIG. 63 toactivate or deactivate the circuit segments in accordance withenergization and deenergization sequences.

The volatile memory 1304, such as a random-access memory (RAM),temporarily stores selected control programs or other software moduleswhile the processor 1302 is in operation, such as when the processor1302 executes a control program or software module. The one or moresensors 1306 may include force sensors, temperature sensors, currentsensors or motion sensors. In some aspects, the one or more sensors 1306may be located at the shaft, end effector, battery, or handle, or anycombination or sub-combination thereof. The one or more sensors 1306transmit data associated with the operation of any one of the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described in connectionwith FIGS. 1-61, such as the presence of tissue grasped by the jaws ofthe end effector or the force applied by the motor. In one aspect, theone or more sensors 1306 may include an accelerometer to verify thefunction or operation of the circuit segments, based on a safety checkand a Power On Self Test (POST). Machine executable instructions such ascontrol programs or other software modules are stored in the nonvolatilememory 1308. For example, the nonvolatile memory 1308 stores the BasicInput/Output System (BIOS) program. The nonvolatile memory 1308 may be aread-only memory, erasable programmable ROM (EPROM), an EEPROM, flashmemory or some other type of nonvolatile memory device. Various examplesof control programs are described in U.S. Pub. No. 2015/0272578, whichis incorporated herein by reference in its entirety. The battery 1310powers the surgical instrument by providing a source voltage that causesa current. The battery 1310 may comprise the motor control circuitsegment 1428 illustrated in FIG. 63.

In one aspect, the processor 1302 may be any single core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In one aspect, the processor 1302 may be implemented as asafety processor comprising two microcontroller-based families such asTMS570 and RM4x known under the trade name Hercules ARM Cortex R4, alsoby Texas Instruments. Nevertheless, other suitable substitutes formicrocontrollers and safety processor may be employed, withoutlimitation. In one aspect, the safety processor may be configuredspecifically for IEC 61508 and ISO 26262 safety critical applications,among others, to provide advanced integrated safety features whiledelivering scalable performance, connectivity, and memory options.

In certain aspects, the processor 1302 may be an LM 4F230H5QR, availablefrom Texas Instruments, for example. In at least one example, the TexasInstruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprisingon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QED analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available for the productdatasheet. Other processors may be readily substituted and, accordingly,the present disclosure should not be limited in this context.

FIG. 63 is a system diagram 1400 of a segmented circuit 1401 comprisinga plurality of independently operated circuit segments 1402, 1414, 1416,1420, 1424, 1428, 1434, 1440, according to one aspect of the presentdisclosure. A circuit segment of the plurality of circuit segments ofthe segmented circuit 1401 comprises one or more circuits and one ormore sets of machine executable instructions stored in one or morememory devices. The one or more circuits of a circuit segment arecoupled to for electrical communication through one or more wired orwireless connection media. The plurality of circuit segments areconfigured to transition between three modes comprising a sleep mode, astandby mode and an operational mode.

In one aspect shown, the plurality of circuit segments 1402, 1414, 1416,1420, 1424, 1428, 1434, 1440 start first in the standby mode, transitionsecond to the sleep mode, and transition third to the operational mode.However, in other aspects, the plurality of circuit segments maytransition from any one of the three modes to any other one of the threemodes. For example, the plurality of circuit segments may transitiondirectly from the standby mode to the operational mode. Individualcircuit segments may be placed in a particular state by the voltagecontrol circuit 1408 based on the execution by the processor 1302 ofmachine executable instructions. The states comprise a deenergizedstate, a low energy state, and an energized state. The deenergized statecorresponds to the sleep mode, the low energy state corresponds to thestandby mode, and the energized state corresponds to the operationalmode. Transition to the low energy state may be achieved by, forexample, the use of a potentiometer.

In one aspect, the plurality of circuit segments 1402, 1414, 1416, 1420,1424, 1428, 1434, 1440 may transition from the sleep mode or the standbymode to the operational mode in accordance with an energizationsequence. The plurality of circuit segments also may transition from theoperational mode to the standby mode or the sleep mode in accordancewith a deenergization sequence. The energization sequence and thedeenergization sequence may be different. In some aspects, theenergization sequence comprises energizing only a subset of circuitsegments of the plurality of circuit segments. In some aspects, thedeenergization sequence comprises deenergizing only a subset of circuitsegments of the plurality of circuit segments.

Referring back to the system diagram 1400 in FIG. 63, the segmentedcircuit 1401 comprise a plurality of circuit segments comprising atransition circuit segment 1402, a processor circuit segment 1414, ahandle circuit segment 1416, a communication circuit segment 1420, adisplay circuit segment 1424, a motor control circuit segment 1428, anenergy treatment circuit segment 1434, and a shaft circuit segment 1440.The transition circuit segment comprises a wake up circuit 1404, a boostcurrent circuit 1406, a voltage control circuit 1408, a safetycontroller 1410 and a POST controller 1412. The transition circuitsegment 1402 is configured to implement a deenergization and anenergization sequence, a safety detection protocol, and a POST.

In some aspects, the wake up circuit 1404 comprises an accelerometerbutton sensor 1405. In aspects, the transition circuit segment 1402 isconfigured to be in an energized state while other circuit segments ofthe plurality of circuit segments of the segmented circuit 1401 areconfigured to be in a low energy state, a deenergized state or anenergized state. The accelerometer button sensor 1405 may monitormovement or acceleration of any one of the surgical instruments 100,480, 500, 600, 1100, 1150, 1200 described herein in connection withFIGS. 1-61. For example, the movement may be a change in orientation orrotation of the surgical instrument. The surgical instrument may bemoved in any direction relative to a three dimensional Euclidean spaceby for example, a user of the surgical instrument. When theaccelerometer button sensor 1405 senses movement or acceleration, theaccelerometer button sensor 1405 sends a signal to the voltage controlcircuit 1408 to cause the voltage control circuit 1408 to apply voltageto the processor circuit segment 1414 to transition the processor 1302and the volatile memory 1304 to an energized state. In aspects, theprocessor 1302 and the volatile memory 1304 are in an energized statebefore the voltage control circuit 1409 applies voltage to the processor1302 and the volatile memory 1304. In the operational mode, theprocessor 1302 may initiate an energization sequence or a deenergizationsequence. In various aspects, the accelerometer button sensor 1405 mayalso send a signal to the processor 1302 to cause the processor 1302 toinitiate an energization sequence or a deenergization sequence. In someaspects, the processor 1302 initiates an energization sequence when themajority of individual circuit segments are in a low energy state or adeenergized state. In other aspects, the processor 1302 initiates adeenergization sequence when the majority of individual circuit segmentsare in an energized state.

Additionally or alternatively, the accelerometer button sensor 1405 maysense external movement within a predetermined vicinity of the surgicalinstrument. For example, the accelerometer button sensor 1405 may sensea user of any one of the surgical instruments 100, 480, 500, 600, 1100,1150, 1200 described herein in connection with FIGS. 1-61 moving a handof the user within the predetermined vicinity. When the accelerometerbutton sensor 1405 senses this external movement, the accelerometerbutton sensor 1405 may send a signal to the voltage control circuit 1408and a signal to the processor 1302, as previously described. Afterreceiving the sent signal, the processor 1302 may initiate anenergization sequence or a deenergization sequence to transition one ormore circuit segments between the three modes. In aspects, the signalsent to the voltage control circuit 1408 is sent to verify that theprocessor 1302 is in operational mode. In some aspects, theaccelerometer button sensor 1405 may sense when the surgical instrumenthas been dropped and send a signal to the processor 1302 based on thesensed drop. For example, the signal can indicate an error in theoperation of an individual circuit segment. The one or more sensors 1306may sense damage or malfunctioning of the affected individual circuitsegments. Based on the sensed damage or malfunctioning, the POSTcontroller 1412 may perform a POST of the corresponding individualcircuit segments.

An energization sequence or a deenergization sequence may be definedbased on the accelerometer button sensor 1405. For example, theaccelerometer button sensor 1405 may sense a particular motion or asequence of motions that indicates the selection of a particular circuitsegment of the plurality of circuit segments. Based on the sensed motionor series of sensed motions, the accelerometer button sensor 1405 maytransmit a signal comprising an indication of one or more circuitsegments of the plurality of circuit segments to the processor 1302 whenthe processor 1302 is in an energized state. Based on the signal, theprocessor 1302 determines an energization sequence comprising theselected one or more circuit segments. Additionally or alternatively, auser of any one of the surgical instruments 100, 480, 500, 600, 1100,1150, 1200 described herein in connection with FIGS. 1-61 may select anumber and order of circuit segments to define an energization sequenceor a deenergization sequence based on interaction with a graphical userinterface (GUI) of the surgical instrument.

In various aspects, the accelerometer button sensor 1405 may send asignal to the voltage control circuit 1408 and a signal to the processor1302 only when the accelerometer button sensor 1405 detects movement ofany one the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 or external movementwithin a predetermined vicinity above a predetermined threshold. Forexample, a signal may only be sent if movement is sensed for 5 or moreseconds or if the surgical instrument is moved 5 or more inches. Inother aspects, the accelerometer button sensor 1405 may send a signal tothe voltage control circuit 1408 and a signal to the processor 1302 onlywhen the accelerometer button sensor 1405 detects oscillating movementof the surgical instrument. A predetermined threshold reducesinadvertent transition of circuit segments of the surgical instrument.As previously described, the transition may comprise a transition tooperational mode according to an energization sequence, a transition tolow energy mode according to a deenergization sequence, or a transitionto sleep mode according to a deenergization sequence. In some aspects,the surgical instrument comprises an actuator that may be actuated by auser of the surgical instrument. The actuation is sensed by theaccelerometer button sensor 1405. The actuator may be a slider, a toggleswitch, or a momentary contact switch. Based on the sensed actuation,the accelerometer button sensor 1405 may send a signal to the voltagecontrol circuit 1408 and a signal to the processor 1302.

The boost current circuit 1406 is coupled to the battery 1310. The boostcurrent circuit 1406 is a current amplifier, such as a relay ortransistor, and is configured to amplify the magnitude of a current ofan individual circuit segment. The initial magnitude of the currentcorresponds to the source voltage provided by the battery 1310 to thesegmented circuit 1401. Suitable relays include solenoids. Suitabletransistors include field-effect transistors (FET), MOSFET, and bipolarjunction transistors (BJT). The boost current circuit 1406 may amplifythe magnitude of the current corresponding to an individual circuitsegment or circuit which requires more current draw during operation ofany one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described in connection with FIGS. 1-61. For example, an increase incurrent to the motor control circuit segment 1428 may be provided when amotor of the surgical instrument requires more input power. The increasein current provided to an individual circuit segment may cause acorresponding decrease in current of another circuit segment or circuitsegments. Additionally or alternatively, the increase in current maycorrespond to voltage provided by an additional voltage source operatingin conjunction with the battery 1310.

The voltage control circuit 1408 is coupled to the battery 1310. Thevoltage control circuit 1408 is configured to provide voltage to orremove voltage from the plurality of circuit segments. The voltagecontrol circuit 1408 is also configured to increase or reduce voltageprovided to the plurality of circuit segments of the segmented circuit1401. In various aspects, the voltage control circuit 1408 comprises acombinational logic circuit such as a multiplexer (MUX) to selectinputs, a plurality of electronic switches, and a plurality of voltageconverters. An electronic switch of the plurality of electronic switchesmay be configured to switch between an open and closed configuration todisconnect or connect an individual circuit segment to or from thebattery 1310. The plurality of electronic switches may be solid statedevices such as transistors or other types of switches such as wirelessswitches, ultrasonic switches, accelerometers, inertial sensors, amongothers. The combinational logic circuit is configured to select anindividual electronic switch for switching to an open configuration toenable application of voltage to the corresponding circuit segment. Thecombination logic circuit also is configured to select an individualelectronic switch for switching to a closed configuration to enableremoval of voltage from the corresponding circuit segment. By selectinga plurality of individual electronic switches, the combination logiccircuit may implement a deenergization sequence or an energizationsequence. The plurality of voltage converters may provide a stepped-upvoltage or a stepped-down voltage to the plurality of circuit segments.The voltage control circuit 1408 may also comprise a microprocessor andmemory device, as illustrated in FIG. 62.

The safety controller 1410 is configured to perform safety checks forthe circuit segments. In some aspects, the safety controller 1410performs the safety checks when one or more individual circuit segmentsare in the operational mode. The safety checks may be performed todetermine whether there are any errors or defects in the functioning oroperation of the circuit segments. The safety controller 1410 maymonitor one or more parameters of the plurality of circuit segments. Thesafety controller 1410 may verify the identity and operation of theplurality of circuit segments by comparing the one or more parameterswith predefined parameters. For example, if an RF energy modality isselected, the safety controller 1410 may verify that an articulationparameter of the shaft matches a predefined articulation parameter toverify the operation of the RF energy modality of any one of thesurgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described inconnection with FIGS. 1-61. In some aspects, the safety controller 1410may monitor, by the sensors 1306, a predetermined relationship betweenone or more properties of the surgical instrument to detect a fault. Afault may arise when the one or more properties are inconsistent withthe predetermined relationship. When the safety controller 1410determines that a fault exists, an error exists, or that some operationof the plurality of circuit segments was not verified, the safetycontroller 1410 prevents or disables operation of the particular circuitsegment where the fault, error or verification failure originated.

The POST controller 1412 performs a POST to verify proper operation ofthe plurality of circuit segments. In some aspects, the POST isperformed for an individual circuit segment of the plurality of circuitsegments prior to the voltage control circuit 1408 applying a voltage tothe individual circuit segment to transition the individual circuitsegment from standby mode or sleep mode to operational mode. If theindividual circuit segment does not pass the POST, the particularcircuit segment does not transition from standby mode or sleep mode tooperational mode. POST of the handle circuit segment 1416 may comprise,for example, testing whether the handle control sensors 1418 sense anactuation of a handle control of any one of the surgical instruments100, 480, 500, 600, 1100, 1150, 1200 described in connection with FIGS.1-61. In some aspects, the POST controller 1412 may transmit a signal tothe accelerometer button sensor 1405 to verify the operation of theindividual circuit segment as part of the POST. For example, afterreceiving the signal, the accelerometer button sensor 1405 may prompt auser of the surgical instrument to move the surgical instrument to aplurality of varying locations to confirm operation of the surgicalinstrument. The accelerometer button sensor 1405 may also monitor anoutput of a circuit segment or a circuit of a circuit segment as part ofthe POST. For example, the accelerometer button sensor 1405 can sense anincremental motor pulse generated by the motor 1432 to verify operation.A motor controller of the motor control circuit 1430 may be used tocontrol the motor 1432 to generate the incremental motor pulse.

In various aspects, any one of the surgical instruments 100, 480, 500,600, 1100, 1150, 1200 described in connection with FIGS. 1-61 maycomprise additional accelerometer button sensors may be used. The POSTcontroller 1412 may also execute a control program stored in the memorydevice of the voltage control circuit 1408. The control program maycause the POST controller 1412 to transmit a signal requesting amatching encrypted parameter from a plurality of circuit segments.Failure to receive a matching encrypted parameter from an individualcircuit segment indicates to the POST controller 1412 that thecorresponding circuit segment is damaged or malfunctioning. In someaspects, if the POST controller 1412 determines based on the POST thatthe processor 1302 is damaged or malfunctioning, the POST controller1412 may send a signal to one or more secondary processors to cause oneor more secondary processors to perform critical functions that theprocessor 1302 is unable to perform. In some aspects, if the POSTcontroller 1412 determines based on the POST that one or more circuitsegments do not operate properly, the POST controller 1412 may initiatea reduced performance mode of those circuit segments operating properlywhile locking out those circuit segments that fail POST or do notoperate properly. A locked out circuit segment may function similarly toa circuit segment in standby mode or sleep mode.

The processor circuit segment 1414 comprises the processor 1302 and thevolatile memory 1304 described with reference to FIG. 62. The processor1302 is configured to initiate an energization or a deenergizationsequence. To initiate the energization sequence, the processor 1302transmits an energizing signal to the voltage control circuit 1408 tocause the voltage control circuit 1408 to apply voltage to the pluralityor a subset of the plurality of circuit segments in accordance with theenergization sequence. To initiate the deenergization sequence, theprocessor 1302 transmits a deenergizing signal to the voltage controlcircuit 1408 to cause the voltage control circuit 1408 to remove voltagefrom the plurality or a subset of the plurality of circuit segments inaccordance with the deenergization sequence.

The handle circuit segment 1416 comprises handle control sensors 1418.The handle control sensors 1418 may sense an actuation of one or morehandle controls of any one of the surgical instruments 100, 480, 500,600, 1100, 1150, 1200 described herein in connection with FIGS. 1-61. Invarious aspects, the one or more handle controls comprise a clampcontrol, a release button, an articulation switch, an energy activationbutton, and/or any other suitable handle control. The user may activatethe energy activation button to select between an RF energy mode, anultrasonic energy mode or a combination RF and ultrasonic energy mode.The handle control sensors 1418 may also facilitate attaching a modularhandle to the surgical instrument. For example, the handle controlsensors 1418 may sense proper attachment of the modular handle to thesurgical instrument and indicate the sensed attachment to a user of thesurgical instrument. The LCD display 1426 may provide a graphicalindication of the sensed attachment. In some aspects, the handle controlsensors 1418 senses actuation of the one or more handle controls. Basedon the sensed actuation, the processor 1302 may initiate either anenergization sequence or a deenergization sequence.

The communication circuit segment 1420 comprises a communication circuit1422. The communication circuit 1422 comprises a communication interfaceto facilitate signal communication between the individual circuitsegments of the plurality of circuit segments. In some aspects, thecommunication circuit 1422 provides a path for the modular components ofany one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 to communicateelectrically. For example, a modular shaft and a modular transducer,when attached together to the handle of the surgical instrument, canupload control programs to the handle through the communication circuit1422.

The display circuit segment 1424 comprises a LCD display 1426. The LCDdisplay 1426 may comprise a liquid crystal display screen, LEDindicators, etc. In some aspects, the LCD display 1426 is an organiclight-emitting diode (OLED) screen. The Display 226 may be placed on,embedded in, or located remotely from any one of the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described herein inconnection with FIGS. 1-61. For example, the Display 226 can be placedon the handle of the surgical instrument. The Display 226 is configuredto provide sensory feedback to a user. In various aspects, the LCDdisplay 1426 further comprises a backlight. In some aspects, thesurgical instrument may also comprise audio feedback devices such as aspeaker or a buzzer and tactile feedback devices such as a hapticactuator.

The motor control circuit segment 1428 comprises a motor control circuit1430 coupled to a motor 1432. The motor 1432 is coupled to the processor1302 by a driver and a transistor, such as a FET. In various aspects,the motor control circuit 1430 comprises a motor current sensor insignal communication with the processor 1302 to provide a signalindicative of a measurement of the current draw of the motor to theprocessor 1302. The processor transmits the signal to the Display 226.The Display 226 receives the signal and displays the measurement of thecurrent draw of the motor 1432. The processor 1302 may use the signal,for example, to monitor that the current draw of the motor 1432 existswithin an acceptable range, to compare the current draw to one or moreparameters of the plurality of circuit segments, and to determine one ormore parameters of a patient treatment site. In various aspects, themotor control circuit 1430 comprises a motor controller to control theoperation of the motor. For example, the motor control circuit 1430controls various motor parameters, such as by adjusting the velocity,torque and acceleration of the motor 1432. The adjusting is done basedon the current through the motor 1432 measured by the motor currentsensor.

In various aspects, the motor control circuit 1430 comprises a forcesensor to measure the force and torque generated by the motor 1432. Themotor 1432 is configured to actuate a mechanism of any one of thesurgical instruments 100, 480, 500, 600, 1100, 1150, 1200 describedherein in connection with FIGS. 1-61. For example, the motor 1432 isconfigured to control actuation of the shaft of the surgical instrumentto realize clamping, rotation and articulation functionality. Forexample, the motor 1432 may actuate the shaft to realize a clampingmotion with jaws of the surgical instrument. The motor controller maydetermine whether the material clamped by the jaws is tissue or metal.The motor controller may also determine the extent to which the jawsclamp the material. For example, the motor controller may determine howopen or closed the jaws are based on the derivative of sensed motorcurrent or motor voltage. In some aspects, the motor 1432 is configuredto actuate the transducer to cause the transducer to apply torque to thehandle or to control articulation of the surgical instrument. The motorcurrent sensor may interact with the motor controller to set a motorcurrent limit. When the current meets the predefined threshold limit,the motor controller initiates a corresponding change in a motor controloperation. For example, exceeding the motor current limit causes themotor controller to reduce the current draw of the motor.

The energy treatment circuit segment 1434 comprises a RF amplifier andsafety circuit 1436 and an ultrasonic signal generator circuit 1438 toimplement the energy modular functionality of any one of the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described in connectionwith FIGS. 1-61. In various aspects, the RF amplifier and safety circuit1436 is configured to control the RF modality of the surgical instrumentby generating an RF signal. The ultrasonic signal generator circuit 1438is configured to control the ultrasonic energy modality by generating anultrasonic signal. The RF amplifier and safety circuit 1436 and anultrasonic signal generator circuit 1438 may operate in conjunction tocontrol the combination RF and ultrasonic energy modality.

The shaft circuit segment 1440 comprises a shaft module controller 1442,a modular control actuator 1444, one or more end effector sensors 1446,and a non volatile memory 1448. The shaft module controller 1442 isconfigured to control a plurality of shaft modules comprising thecontrol programs to be executed by the processor 1302. The plurality ofshaft modules implements a shaft modality, such as ultrasonic,combination ultrasonic and RF, RF I-blade, and RF-opposable jaw. Theshaft module controller 1442 can select shaft modality by selecting thecorresponding shaft module for the processor 1302 to execute. Themodular control actuator 1444 is configured to actuate the shaftaccording to the selected shaft modality. After actuation is initiated,the shaft articulates the end effector according to the one or moreparameters, routines or programs specific to the selected shaft modalityand the selected end effector modality. The one or more end effectorsensors 1446 located at the end effector may include force sensors,temperature sensors, current sensors or motion sensors. The one or moreend effector sensors 1446 transmit data about one or more operations ofthe end effector, based on the energy modality implemented by the endeffector. In various aspects, the energy modalities include anultrasonic energy modality, a RF energy modality, or a combination ofthe ultrasonic energy modality and the RF energy modality. The nonvolatile memory 1448 stores the shaft control programs. A controlprogram comprises one or more parameters, routines or programs specificto the shaft. In various aspects, the non volatile memory 1448 may be anROM, EPROM, EEPROM or flash memory. The non volatile memory 1448 storesthe shaft modules corresponding to the selected shaft of nay one of thesurgical instruments 100, 480, 500, 600, 1100, 1150, 1200 describedherein in connection with FIGS. 1-61. The shaft modules may be changedor upgraded in the non volatile memory 1448 by the shaft modulecontroller 1442, depending on the surgical instrument shaft to be usedin operation.

FIG. 64 illustrates a diagram of one aspect of a surgical instrument1500 comprising a feedback system for use with any one of the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described herein inconnection with FIGS. 1-61, which may include or implement many of thefeatures described herein. For example, in one aspect, the surgicalinstrument 1500 may be similar to or representative of any one of thesurgical instruments 100, 480, 500, 600, 1100, 1150, 1200. The surgicalinstrument 1500 may include a generator 1502. The surgical instrument1500 also may include an end effector 1506, which may be activated whena clinician operates a trigger 1510. In various aspects, the endeffector 1506 may include an ultrasonic blade to deliver ultrasonicvibration to carry out surgical coagulation/cutting treatments on livingtissue. In other aspects the end effector 1506 may include electricallyconductive elements coupled to an electrosurgical high-frequency currentenergy source to carry out surgical coagulation or cauterizationtreatments on living tissue and either a mechanical knife with a sharpedge or an ultrasonic blade to carry out cutting treatments on livingtissue. When the trigger 1510 is actuated, a force sensor 1512 maygenerate a signal indicating the amount of force being applied to thetrigger 1510. In addition to, or instead of a force sensor 1512, thesurgical instrument 1500 may include a position sensor 1513, which maygenerate a signal indicating the position of the trigger 1510 (e.g., howfar the trigger has been depressed or otherwise actuated). In oneaspect, the position sensor 1513 may be a sensor positioned with theouter tubular sheath described above or reciprocating tubular actuatingmember located within the outer tubular sheath described above. In oneaspect, the sensor may be a Hall-effect sensor or any suitabletransducer that varies its output voltage in response to a magneticfield. The Hall-effect sensor may be used for proximity switching,positioning, speed detection, and current sensing applications. In oneaspect, the Hall-effect sensor operates as an analog transducer,directly returning a voltage. With a known magnetic field, its distancefrom the Hall plate can be determined.

A control circuit 1508 may receive the signals from the sensors 1512and/or 1513. The control circuit 1508 may include any suitable analog ordigital circuit components. The control circuit 1508 also maycommunicate with the generator 1502 and/or the transducer 1504 tomodulate the power delivered to the end effector 1506 and/or thegenerator level or ultrasonic blade amplitude of the end effector 1506based on the force applied to the trigger 1510 and/or the position ofthe trigger 1510 and/or the position of the outer tubular sheathdescribed above relative to the reciprocating tubular actuating member58 located within the outer tubular sheath 56 described above (e.g., asmeasured by a Hall-effect sensor and magnet combination). For example,as more force is applied to the trigger 1510, more power and/or a higherultrasonic blade amplitude may be delivered to the end effector 1506.According to various aspects, the force sensor 1512 may be replaced by amulti-position switch.

According to various aspects, the end effector 1506 may include a clampor clamping mechanism, for example, such as that described above withrespect to FIGS. 1-5. When the trigger 1510 is initially actuated, theclamping mechanism may close, clamping tissue between a clamp arm andthe end effector 1506. As the force applied to the trigger increases(e.g., as sensed by force sensor 1512) the control circuit 1508 mayincrease the power delivered to the end effector 1506 by the transducer1504 and/or the generator level or ultrasonic blade amplitude broughtabout in the end effector 1506. In one aspect, trigger position, assensed by position sensor 1513 or clamp or clamp arm position, as sensedby position sensor 1513 (e.g., with a Hall-effect sensor), may be usedby the control circuit 1508 to set the power and/or amplitude of the endeffector 1506. For example, as the trigger is moved further towards afully actuated position, or the clamp or clamp arm moves further towardsthe ultrasonic blade (or end effector 1506), the power and/or amplitudeof the end effector 1506 may be increased.

According to various aspects, the surgical instrument 1500 also mayinclude one or more feedback devices for indicating the amount of powerdelivered to the end effector 1506. For example, a speaker 1514 may emita signal indicative of the end effector power. According to variousaspects, the speaker 1514 may emit a series of pulse sounds, where thefrequency of the sounds indicates power. In addition to, or instead ofthe speaker 1514, the surgical instrument 1500 may include a visualdisplay 1516. The visual display 1516 may indicate end effector poweraccording to any suitable method. For example, the visual display 1516may include a series of LEDs, where end effector power is indicated bythe number of illuminated LEDs. The speaker 1514 and/or visual display1516 may be driven by the control circuit 1508. According to variousaspects, the surgical instrument 1500 may include a ratcheting device(not shown) connected to the trigger 1510. The ratcheting device maygenerate an audible sound as more force is applied to the trigger 1510,providing an indirect indication of end effector power. The surgicalinstrument 1500 may include other features that may enhance safety. Forexample, the control circuit 1508 may be configured to prevent powerfrom being delivered to the end effector 1506 in excess of apredetermined threshold. Also, the control circuit 1508 may implement adelay between the time when a change in end effector power is indicated(e.g., by speaker 1514 or visual display 1516), and the time when thechange in end effector power is delivered. In this way, a clinician mayhave ample warning that the level of ultrasonic power that is to bedelivered to the end effector 1506 is about to change.

In one aspect, the ultrasonic or high-frequency current generators ofany one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 may be configured togenerate the electrical signal waveform digitally such that the desiredusing a predetermined number of phase points stored in a lookup table todigitize the wave shape. The phase points may be stored in a tabledefined in a memory, a field programmable gate array (FPGA), or anysuitable non-volatile memory. FIG. 65 illustrates one aspect of afundamental architecture for a digital synthesis circuit such as adirect digital synthesis (DDS) circuit 1600 configured to generate aplurality of wave shapes for the electrical signal waveform. Thegenerator software and digital controls may command the FPGA to scan theaddresses in the lookup table 1604 which in turn provides varyingdigital input values to a DAC circuit 1608 that feeds a power amplifier.The addresses may be scanned according to a frequency of interest. Usingsuch a lookup table 1604 enables generating various types of wave shapesthat can be fed into tissue or into a transducer, an RF electrode,multiple transducers simultaneously, multiple RF electrodessimultaneously, or a combination of RF and ultrasonic instruments.Furthermore, multiple lookup tables 1604 that represent multiple waveshapes can be created, stored, and applied to tissue from a generator.

The waveform signal may be configured to control at least one of anoutput current, an output voltage, or an output power of an ultrasonictransducer and/or an RF electrode, or multiples thereof (e.g. two ormore ultrasonic transducers and/or two or more RF electrodes). Further,where the surgical instrument comprises an ultrasonic components, thewaveform signal may be configured to drive at least two vibration modesof an ultrasonic transducer of the at least one surgical instrument.Accordingly, a generator may be configured to provide a waveform signalto at least one surgical instrument wherein the waveform signalcorresponds to at least one wave shape of a plurality of wave shapes ina table. Further, the waveform signal provided to the two surgicalinstruments may comprise two or more wave shapes. The table may compriseinformation associated with a plurality of wave shapes and the table maybe stored within the generator. In one aspect or example, the table maybe a direct digital synthesis table, which may be stored in an FPGA ofthe generator. The table may be addressed by anyway that is convenientfor categorizing wave shapes. According to one aspect, the table, whichmay be a direct digital synthesis table, is addressed according to afrequency of the waveform signal. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the table.

The analog electrical signal waveform may be configured to control atleast one of an output current, an output voltage, or an output power ofan ultrasonic transducer and/or an RF electrode, or multiples thereof(e.g., two or more ultrasonic transducers and/or two or more RFelectrodes). Further, where the surgical instrument comprises ultrasoniccomponents, the analog electrical signal waveform may be configured todrive at least two vibration modes of an ultrasonic transducer of the atleast one surgical instrument. Accordingly, the generator circuit may beconfigured to provide an analog electrical signal waveform to at leastone surgical instrument wherein the analog electrical signal waveformcorresponds to at least one wave shape of a plurality of wave shapesstored in a lookup table 1604. Further, the analog electrical signalwaveform provided to the two surgical instruments may comprise two ormore wave shapes. The lookup table 1604 may comprise informationassociated with a plurality of wave shapes and the lookup table 1604 maybe stored either within the generator circuit or the surgicalinstrument. In one aspect or example, the lookup table 1604 may be adirect digital synthesis table, which may be stored in an FPGA of thegenerator circuit or the surgical instrument. The lookup table 1604 maybe addressed by anyway that is convenient for categorizing wave shapes.According to one aspect, the lookup table 1604, which may be a directdigital synthesis table, is addressed according to a frequency of thedesired analog electrical signal waveform. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the lookup table 1604.

With the widespread use of digital techniques in instrumentation andcommunications systems, a digitally-controlled method of generatingmultiple frequencies from a reference frequency source has evolved andis referred to as direct digital synthesis. The basic architecture isshown in FIG. 65. In this simplified block diagram, a DDS circuit iscoupled to a processor, controller, or a logic device of the generatorcircuit and to a memory circuit located either in the generator circuitof any one of the surgical instruments 100, 480, 500, 600, 1100, 1150,1200 described herein in connection with FIGS. 1-61. The DDS circuit1600 comprises an address counter 1602, lookup table 1604, a register1606, a DAC circuit 1608, and a filter 1612. A stable clock f_(c) isreceived by the address counter 1602 and the register 1606 drives aprogrammable-read-only-memory (PROM) which stores one or more integralnumber of cycles of a sine wave (or other arbitrary waveform) in alookup table 1604. As the address counter 1602 steps through memorylocations, values stored in the lookup table 1604 are written to aregister 1606, which is coupled to a DAC circuit 1608. The correspondingdigital amplitude of the signal at the memory location of the lookuptable 1604 drives the DAC circuit 1608, which in turn generates ananalog output signal 1610. The spectral purity of the analog outputsignal 1610 is determined primarily by the DAC circuit 1608. The phasenoise is basically that of the reference clock f_(c). The first analogoutput signal 1610 output from the DAC circuit 1608 is filtered by thefilter 1612 and a second analog output signal 1614 output by the filter1612 is provided to an amplifier having an output coupled to the outputof the generator circuit. The second analog output signal has afrequency f_(out).

Because the DDS circuit 1600 is a sampled data system, issues involvedin sampling must be considered: quantization noise, aliasing, filtering,etc. For instance, the higher order harmonics of the DAC circuit 1608output frequencies fold back into the Nyquist bandwidth, making themunfilterable, whereas, the higher order harmonics of the output ofphase-locked-loop (PLL) based synthesizers can be filtered. The lookuptable 1604 contains signal data for an integral number of cycles. Thefinal output frequency f_(out) can be changed changing the referenceclock frequency f_(c) or by reprogramming the PROM.

The DDS circuit 1600 may comprise multiple lookup tables 1604 where thelookup table 1604 stores a waveform represented by a predeterminednumber of samples, wherein the samples define a predetermined shape ofthe waveform. Thus multiple waveforms having a unique shape can bestored in multiple lookup tables 1604 to provide different tissuetreatments based on instrument settings or tissue feedback. Examples ofwaveforms include high crest factor RF electrical signal waveforms forsurface tissue coagulation, low crest factor RF electrical signalwaveform for deeper tissue penetration, and electrical signal waveformsthat promote efficient touch-up coagulation. In one aspect, the DDScircuit 1600 can create multiple wave shape lookup tables 1604 andduring a tissue treatment procedure (e.g., “on-the-fly” or in virtualreal time based on user or sensor inputs) switch between different waveshapes stored in separate lookup tables 1604 based on the tissue effectdesired and/or tissue feedback. Accordingly, switching between waveshapes can be based on tissue impedance and other factors, for example.In other aspects, the lookup tables 1604 can store electrical signalwaveforms shaped to maximize the power delivered into the tissue percycle (i.e., trapezoidal or square wave). In other aspects, the lookuptables 1604 can store wave shapes synchronized in such way that theymake maximizing power delivery by the multifunction surgical instrumentany one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 while delivering RF andultrasonic drive signals. In yet other aspects, the lookup tables 1604can store electrical signal waveforms to drive ultrasonic and RFtherapeutic, and/or sub-therapeutic, energy simultaneously whilemaintaining ultrasonic frequency lock. Custom wave shapes specific todifferent instruments and their tissue effects can be stored in thenon-volatile memory of the generator circuit or in the non-volatilememory (e.g., EEPROM) of any one of the surgical instruments 100, 480,500, 600, 1100, 1150, 1200 described herein in connection with FIGS.1-61 and be fetched upon connecting the multifunction surgicalinstrument to the generator circuit. An example of an exponentiallydamped sinusoid, as used in many high crest factor “coagulation”waveforms is shown in FIG. 67.

A more flexible and efficient implementation of the DDS circuit 1600employs a digital circuit called a Numerically Controlled Oscillator(NCO). A block diagram of a more flexible and efficient digitalsynthesis circuit such as a DDS circuit 1700 is shown in FIG. 66. Inthis simplified block diagram, a DDS circuit 1700 is coupled to aprocessor, controller, or a logic device of the generator and to amemory circuit located either in the generator or in any of the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described herein inconnection with FIGS. 1-61. The DDS circuit 1700 comprises a loadregister 1702, a parallel delta phase register 1704, an adder circuit1716, a phase register 1708, a lookup table 1710 (phase-to-amplitudeconverter), a DAC circuit 1712, and a filter 1714. The adder circuit1716 and the phase register 1708 a form part of a phase accumulator1706. A clock signal f_(c) is applied to the phase register 1708 and theDAC circuit 1712. The load register 1702 receives a tuning word thatspecifies output frequency as a fraction of the reference clockfrequency f_(c). The output of the load register 1702 is provided to aparallel delta phase register 1704 with a tuning word M.

The DDS circuit 1700 includes a sample clock that generates a clockfrequency f_(c), a phase accumulator 1706, and a lookup table 1710(e.g., phase to amplitude converter). The content of the phaseaccumulator 1706 is updated once per clock cycle f_(c). When time thephase accumulator 1706 is updated, the digital number, M, stored in theparallel delta phase register 1704 is added to the number in the phaseregister 1708 by an adder circuit 1716. Assuming that the number in theparallel delta phase register 1704 is 00 . . . 01 and that the initialcontents of the phase accumulator 1706 is 00 . . . 00. The phaseaccumulator 1706 is updated by 00 . . . 01 per clock cycle. If the phaseaccumulator 1706 is 32-bits wide, 232 clock cycles (over 4 billion) arerequired before the phase accumulator 1706 returns to 00 . . . 00, andthe cycle repeats.

The truncated output 1718 of the phase accumulator 1706 is provided to aphase-to amplitude converter lookup table 1710 and the output of thelookup table 1710 is coupled to a DAC circuit 1712. The truncated output1718 of the phase accumulator 1706 serves as the address to a sine (orcosine) lookup table. An address in the lookup table corresponds to aphase point on the sine wave from 0° to 360°. The lookup table 1710contains the corresponding digital amplitude information for onecomplete cycle of a sine wave. The lookup table 1710 therefore maps thephase information from the phase accumulator 1706 into a digitalamplitude word, which in turn drives the DAC circuit 1712. The output ofthe DAC circuit is a first analog signal 1720 and is filtered by afilter 1714. The output of the filter 1714 is a second analog signal1722, which is provided to a power amplifier coupled to the output ofthe generator circuit.

In one aspect, the electrical signal waveform may be digitized into 1024(210) phase points, although the wave shape may be digitized is anysuitable number of 2n phase points ranging from 256 (28) to281,474,976,710,656 (248), where n is a positive integer, as shown inTABLE 1. The electrical signal waveform may be expressed as An(θn),where a normalized amplitude An at a point n is represented by a phaseangle θn is referred to as a phase point at point n. The number ofdiscrete phase points n determines the tuning resolution of the DDScircuit 1700 (as well as the DDS circuit 1600 shown in FIG. 65).

TABLE 1 N Number of Phase Points 2^(n)  8 256 10 1,024 12 4,096 1416,384 16 65,536 18 262,144 20 1,048,576 22 4,194,304 24 16,777,216 2667,108,864 28 268,435,456 . . . . . . 32 4,294,967,296 . . . . . . 48281,474,976,710,656 . . . . . .

The generator circuit algorithms and digital control circuits scan theaddresses in the lookup table 1710, which in turn provides varyingdigital input values to the DAC circuit 1712 that feeds the filter 1714and the power amplifier. The addresses may be scanned according to afrequency of interest. Using the lookup table enables generating varioustypes of shapes that can be converted into an analog output signal bythe DAC circuit 1712, filtered by the filter 1714, amplified by thepower amplifier coupled to the output of the generator circuit, and fedto the tissue in the form of RF energy or fed to an ultrasonictransducer and applied to the tissue in the form of ultrasonicvibrations which deliver energy to the tissue in the form of heat. Theoutput of the amplifier can be applied to an RF electrode, multiple RFelectrodes simultaneously, an ultrasonic transducer, multiple ultrasonictransducers simultaneously, or a combination of RF and ultrasonictransducers, for example. Furthermore, multiple wave shape tables can becreated, stored, and applied to tissue from a generator circuit.

With reference back to FIG. 65, for n=32, and M=1, the phase accumulator1706 steps through 232 possible outputs before it overflows andrestarts. The corresponding output wave frequency is equal to the inputclock frequency divided by 232. If M=2, then the phase register 1708“rolls over” twice as fast, and the output frequency is doubled. Thiscan be generalized as follows.

For a phase accumulator 1706 configured to accumulate n-bits (ngenerally ranges from 24 to 32 in most DDS systems, but as previouslydiscussed n may be selected from a wide range of options), there are2^(n) possible phase points. The digital word in the delta phaseregister, M, represents the amount the phase accumulator is incrementedper clock cycle. If fc is the clock frequency, then the frequency of theoutput sine wave is equal to:

$\begin{matrix}f_{o = \frac{M \cdot f_{c}}{2^{n}}} & {{Eq}.\mspace{14mu} 1}\end{matrix}$

Equation 1 is known as the DDS “tuning equation.” Note that thefrequency resolution of the system is equal to

$\frac{f_{o}}{2^{n}}.$For n=32, the resolution is greater than one part in four billion. Inone aspect of the DDS circuit 1700, not all of the bits out of the phaseaccumulator 1706 are passed on to the lookup table 1710, but aretruncated, leaving only the first 13 to 15 most significant bits (MSBs),for example. This reduces the size of the lookup table 1710 and does notaffect the frequency resolution. The phase truncation only adds a smallbut acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by a current,voltage, or power at a predetermined frequency. Further, where any oneof the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 comprises ultrasoniccomponents, the electrical signal waveform may be configured to drive atleast two vibration modes of an ultrasonic transducer of the at leastone surgical instrument. Accordingly, the generator circuit may beconfigured to provide an electrical signal waveform to at least onesurgical instrument wherein the electrical signal waveform ischaracterized by a predetermined wave shape stored in the lookup table1710 (or lookup table 1604 FIG. 65). Further, the electrical signalwaveform may be a combination of two or more wave shapes. The lookuptable 1710 may comprise information associated with a plurality of waveshapes. In one aspect or example, the lookup table 1710 may be generatedby the DDS circuit 1700 and may be referred to as a direct digitalsynthesis table. DDS works by first storing a large repetitive waveformin onboard memory. A cycle of a waveform (sine, triangle, square,arbitrary) can be represented by a predetermined number of phase pointsas shown in TABLE 1 and stored into memory. Once the waveform is storedinto memory, it can be generated at very precise frequencies. The directdigital synthesis table may be stored in a non-volatile memory of thegenerator circuit and/or may be implemented with a FPGA circuit in thegenerator circuit. The lookup table 1710 may be addressed by anysuitable technique that is convenient for categorizing wave shapes.According to one aspect, the lookup table 1710 is addressed according toa frequency of the electrical signal waveform. Additionally, theinformation associated with the plurality of wave shapes may be storedas digital information in a memory or as part of the lookup table 1710.

In one aspect, the generator circuit may be configured to provideelectrical signal waveforms to at least two surgical instrumentssimultaneously. The generator circuit also may be configured to providethe electrical signal waveform, which may be characterized two or morewave shapes, via an output channel of the generator circuit to the twosurgical instruments simultaneously. For example, in one aspect theelectrical signal waveform comprises a first electrical signal to drivean ultrasonic transducer (e.g., ultrasonic drive signal), a second RFdrive signal, and/or a combination thereof. In addition, an electricalsignal waveform may comprise a plurality of ultrasonic drive signals, aplurality of RF drive signals, and/or a combination of a plurality ofultrasonic and RF drive signals.

In addition, a method of operating the generator circuit according tothe present disclosure comprises generating an electrical signalwaveform and providing the generated electrical signal waveform to anyone of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61, where generating theelectrical signal waveform comprises receiving information associatedwith the electrical signal waveform from a memory. The generatedelectrical signal waveform comprises at least one wave shape.Furthermore, providing the generated electrical signal waveform to theat least one surgical instrument comprises providing the electricalsignal waveform to at least two surgical instruments simultaneously.

The generator circuit as described herein may allow for the generationof various types of direct digital synthesis tables. Examples of waveshapes for RF/Electrosurgery signals suitable for treating a variety oftissue generated by the generator circuit include RF signals with a highcrest factor (which may be used for surface coagulation in RF mode), alow crest factor RF signals (which may be used for deeper tissuepenetration), and waveforms that promote efficient touch-up coagulation.The generator circuit also may generate multiple wave shapes employing adirect digital synthesis lookup table 1710 and, on the fly, can switchbetween particular wave shapes based on the desired tissue effect.Switching may be based on tissue impedance and/or other factors.

In addition to traditional sine/cosine wave shapes, the generatorcircuit may be configured to generate wave shape(s) that maximize thepower into tissue per cycle (i.e., trapezoidal or square wave). Thegenerator circuit may provide wave shape(s) that are synchronized tomaximize the power delivered to the load when driving RF and ultrasonicsignals simultaneously and to maintain ultrasonic frequency lock,provided that the generator circuit includes a circuit topology thatenables simultaneously driving RF and ultrasonic signals. Further,custom wave shapes specific to instruments and their tissue effects canbe stored in a non-volatile memory (NVM) or an instrument EEPROM and canbe fetched upon connecting any one of the surgical instruments 100, 480,500, 600, 1100, 1150, 1200 described herein in connection with FIGS.1-61 to the generator circuit.

The DDS circuit 1700 may comprise multiple lookup tables 1604 where thelookup table 1710 stores a waveform represented by a predeterminednumber of phase points (also may be referred to as samples), wherein thephase points define a predetermined shape of the waveform. Thus multiplewaveforms having a unique shape can be stored in multiple lookup tables1710 to provide different tissue treatments based on instrument settingsor tissue feedback. Examples of waveforms include high crest factor RFelectrical signal waveforms for surface tissue coagulation, low crestfactor RF electrical signal waveform for deeper tissue penetration, andelectrical signal waveforms that promote efficient touch-up coagulation.In one aspect, the DDS circuit 1700 can create multiple wave shapelookup tables 1710 and during a tissue treatment procedure (e.g.,“on-the-fly” or in virtual real time based on user or sensor inputs)switch between different wave shapes stored in different lookup tables1710 based on the tissue effect desired and/or tissue feedback.Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 1710 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 1710 can store wave shapessynchronized in such way that they make maximizing power delivery by anyone of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200described herein in connection with FIGS. 1-61 when delivering RF andultrasonic drive signals. In yet other aspects, the lookup tables 1710can store electrical signal waveforms to drive ultrasonic and RFtherapeutic, and/or sub-therapeutic, energy simultaneously whilemaintaining ultrasonic frequency lock. Generally, the output wave shapemay be in the form of a sine wave, cosine wave, pulse wave, square wave,and the like. Nevertheless, the more complex and custom wave shapesspecific to different instruments and their tissue effects can be storedin the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical instrument and befetched upon connecting the surgical instrument to the generatorcircuit. One example of a custom wave shape is an exponentially dampedsinusoid as used in many high crest factor “coagulation” waveforms, asshown in FIG. 67.

FIG. 67 illustrates one cycle of a discrete time digital electricalsignal waveform 1800, according to one aspect of the present disclosureof an analog waveform 1804 (shown superimposed over the discrete timedigital electrical signal waveform 1800 for comparison purposes). Thehorizontal axis represents Time (t) and the vertical axis representsdigital phase points. The digital electrical signal waveform 1800 is adigital discrete time version of the desired analog waveform 1804, forexample. The digital electrical signal waveform 1800 is generated bystoring an amplitude phase point 1802 that represents the amplitude perclock cycle T_(clk) over one cycle or period T_(o). The digitalelectrical signal waveform 1800 is generated over one period T_(o) byany suitable digital processing circuit. The amplitude phase points aredigital words stored in a memory circuit. In the example illustrated inFIGS. 65, 66, the digital word is a six-bit word that is capable ofstoring the amplitude phase points with a resolution of 26 or 64 bits.It will be appreciated that the examples shown in FIGS. 65, 66 is forillustrative purposes and in actual implementations the resolution canbe much higher. The digital amplitude phase points 1802 over one cycleT_(o) are stored in the memory as a string of string words in a lookuptable 1604, 1710 as described in connection with FIGS. 65, 66, forexample. To generate the analog version of the analog waveform 1804, theamplitude phase points 1802 are read sequentially from the memory from 0to T_(o) per clock cycle T_(clk) and are converted by a DAC circuit1608, 1712, also described in connection with FIGS. 65, 66. Additionalcycles can be generated by repeatedly reading the amplitude phase points1802 of the digital electrical signal waveform 1800 the from 0 to T_(o)for as many cycles or periods as may be desired. The smooth analogversion of the analog waveform 1804 is achieved by filtering the outputof the DAC circuit 1608, 1712 by a filter 1612, 1714 (FIGS. 65 and 66).The filtered analog output signal 1614, 1722 (FIGS. 65 and 66) isapplied to the input of a power amplifier.

In one aspect, as illustrated in FIG. 68A, a circuit 1900 may comprise acontroller comprising one or more processors 1902 (e.g., microprocessor,microcontroller) coupled to at least one memory circuit 1904. The atleast one memory circuit 1904 stores machine executable instructionsthat when executed by the processor 1902, cause the processor 1902 toexecute machine instructions to implement any of the algorithms,processes, or techniques described herein.

The processor 1902 may be any one of a number of single or multi-coreprocessors known in the art. The memory circuit 1904 may comprisevolatile and non-volatile storage media. In one aspect, as illustratedin FIG. 68A, the processor 1902 may include an instruction processingunit 1906 and an arithmetic unit 1908. The instruction processing unitmay be configured to receive instructions from the one memory circuit1904.

In one aspect, a circuit 1910 may comprise a finite state machinecomprising a combinational logic circuit 1912, as illustrated in FIG.68B, configured to implement any of the algorithms, processes, ortechniques described herein. In one aspect, a circuit 1920 may comprisea finite state machine comprising a sequential logic circuit, asillustrated in FIG. 68C. The sequential logic circuit 1920 may comprisethe combinational logic circuit 1912 and at least one memory circuit1914, for example. The at least one memory circuit 1914 can store acurrent state of the finite state machine, as illustrated in FIG. 68C.The sequential logic circuit 1920 or the combinational logic circuit1912 can be configured to implement any of the algorithms, processes, ortechniques described herein. In certain instances, the sequential logiccircuit 1920 may be synchronous or asynchronous.

In other aspects, the circuit may comprise a combination of theprocessor 1902 and the finite state machine to implement any of thealgorithms, processes, or techniques described herein. In other aspects,the finite state machine may comprise a combination of the combinationallogic circuit 1910 and the sequential logic circuit 1920.

FIG. 69 is a schematic diagram of a circuit 1925 of various componentsof a surgical instrument with motor control functions, according to oneaspect of the present disclosure. In various aspects, the surgicalinstruments 100, 480, 500, 600, 1100, 1150, 1200 described herein inconnection with FIGS. 1-68C may include a drive mechanism 1930 which isconfigured to drive shafts and/or gear components in order to performthe various operations associated with the surgical instruments 100,480, 500, 600, 1100, 1150, 1200. In one aspect, the drive mechanism 1930160 includes a rotation drivetrain 1932 configured to rotate endeffector 112, 512, 1000, 1112, 1212 as described in connection withFIGS. 1, 20, 40, 41, 45, 54, for example, about a longitudinal axisrelative to handle housing. The drive mechanism 1930 further includes aclosure drivetrain 1934 configured to close a jaw member to grasp tissuewith the end effector. In addition, the drive mechanism 1930 includes afiring drive train 1936 configured to fire an I-beam knife of the endeffector to cut tissue grasped by the end effector.

The drive mechanism 1930 includes a selector gearbox assembly 1938 thatcan be located in the handle assembly of the surgical instrument.Proximal to the selector gearbox assembly 1938 is a function selectionmodule which includes a first motor 1942 that functions to selectivelymove gear elements within the selector gearbox assembly 1938 toselectively position one of the drivetrains 1932, 1934, 1936 intoengagement with an input drive component of an optional second motor1944 and motor drive circuit 1946 (shown in dashed line to indicate thatthe second motor 1944 and motor drive circuit 1946 are optionalcomponents).

Still referring to FIG. 69, the motors 1942, 1944 are coupled to motorcontrol circuits 1946, 1948, respectively, which are configured tocontrol the operation of the motors 1942, 1944 including the flow ofelectrical energy from a power source 1950 to the motors 1942, 1944. Thepower source 1950 may be a DC battery (e.g., rechargeable lead-based,nickel-based, lithium-ion based, battery etc.) or any other power sourcesuitable for providing electrical energy to the surgical instrument.

The surgical instrument further includes a microcontroller 1952(“controller”). In certain instances, the controller 1952 may include amicroprocessor 1954 (“processor”) and one or more computer readablemediums or memory units 1956 (“memory”). In certain instances, thememory 1956 may store various program instructions, which when executedmay cause the processor 1954 to perform a plurality of functions and/orcalculations described herein. The power source 1950 can be configuredto supply power to the controller 1952, for example.

The processor 1954 be in communication with the motor control circuit1946. In addition, the memory 1956 may store program instructions, whichwhen executed by the processor 1954 in response to a user input 1958 orfeedback elements 1960, may cause the motor control circuit 1946 tomotivate the motor 1942 to generate at least one rotational motion toselectively move gear elements within the selector gearbox assembly 1938to selectively position one of the drivetrains 1932, 1934, 1936 intoengagement with the input drive component of the second motor 1944.Furthermore, the processor 1954 can be in communication with the motorcontrol circuit 1948. The memory 1956 also may store programinstructions, which when executed by the processor 1954 in response to auser input 1958, may cause the motor control circuit 1948 to motivatethe motor 1944 to generate at least one rotational motion to drive thedrivetrain engaged with the input drive component of the second motor1948, for example.

The controller 1952 and/or other controllers of the present disclosuremay be implemented using integrated and/or discrete hardware elements,software elements, and/or a combination of both. Examples of integratedhardware elements may include processors, microprocessors,microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logicgates, registers, semiconductor devices, chips, microchips, chip sets,microcontrollers, system on a chip (SoC), and/or single in-line package(SIP). Examples of discrete hardware elements may include circuitsand/or circuit elements such as logic gates, field effect transistors,bipolar transistors, resistors, capacitors, inductors, and/or relays. Incertain instances, the controller 1952 may include a hybrid circuitcomprising discrete and integrated circuit elements or components on oneor more substrates, for example.

In certain instances, the controller 1952 and/or other controllers ofthe present disclosure may be an LM 4F230H5QR, available from TexasInstruments, for example. In certain instances, the Texas InstrumentsLM4F230H5QR is an ARM Cortex-M4F Processor Core comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle SRAM, internal ROM loaded with StellarisWare®software, 2 KB EEPROM, one or more PWM modules, one or more QEI analog,one or more 12-bit ADC with 12 analog input channels, among otherfeatures that are readily available. Other microcontrollers may bereadily substituted for use with the present disclosure. Accordingly,the present disclosure should not be limited in this context.

In various instances, one or more of the various steps described hereincan be performed by a finite state machine comprising either acombinational logic circuit or a sequential logic circuit, where eitherthe combinational logic circuit or the sequential logic circuit iscoupled to at least one memory circuit. The at least one memory circuitstores a current state of the finite state machine. The combinational orsequential logic circuit is configured to cause the finite state machineto the steps. The sequential logic circuit may be synchronous orasynchronous. In other instances, one or more of the various stepsdescribed herein can be performed by a circuit that includes acombination of the processor 1958 and the finite state machine, forexample.

In various instances, it can be advantageous to be able to assess thestate of the functionality of a surgical instrument to ensure its properfunction. It is possible, for example, for the drive mechanism, asexplained above, which is configured to include various motors,drivetrains, and/or gear components in order to perform the variousoperations of the surgical instrument, to wear out over time. This canoccur through normal use, and in some instances the drive mechanism canwear out faster due to abuse conditions. In certain instances, asurgical instrument can be configured to perform self-assessments todetermine the state, e.g. health, of the drive mechanism and it variouscomponents.

For example, the self-assessment can be used to determine when thesurgical instrument is capable of performing its function before are-sterilization or when some of the components should be replacedand/or repaired. Assessment of the drive mechanism and its components,including but not limited to the rotation drivetrain 1932, the closuredrivetrain 1934, and/or the firing drivetrain 1936, can be accomplishedin a variety of ways. The magnitude of deviation from a predictedperformance can be used to determine the likelihood of a sensed failureand the severity of such failure. Several metrics can be used including:Periodic analysis of repeatably predictable events, Peaks or drops thatexceed an expected threshold, and width of the failure.

In various instances, a signature waveform of a properly functioningdrive mechanism or one or more of its components can be employed toassess the state of the drive mechanism or the one or more of itscomponents. One or more vibration sensors can be arranged with respectto a properly functioning drive mechanism or one or more of itscomponents to record various vibrations that occur during operation ofthe properly functioning drive mechanism or the one or more of itscomponents. The recorded vibrations can be employed to create thesignature waveform. Future waveforms can be compared against thesignature waveform to assess the state of the drive mechanism and itscomponents.

Still referring to FIG. 69, the surgical instrument 1930 includes adrivetrain failure detection module 1962 configured to record andanalyze one or more acoustic outputs of one or more of the drivetrains1932, 1934, 1936. The processor 1954 can be in communication with orotherwise control the module 1962. As described below in greater detail,the module 1962 can be embodied as various means, such as circuitry,hardware, a computer program product comprising a computer readablemedium (for example, the memory 1956) storing computer readable programinstructions that are executable by a processing device (for example,the processor 1954), or some combination thereof. In some aspects, theprocessor 36 can include, or otherwise control the module 1962.

FIG. 70 illustrates a handle assembly 1970 with a removable servicepanel 1972 removed to shown internal components of the handle assembly,according to one aspect of the present disclosure. The removable servicepanel 1972, or removable service cover, also includes reinforcing ribs1990 for strength. The removable service panel 1972 comprises aplurality of fasteners 1988 that mate with a plurality of fasteners 1986on the handle housing 1974 to removably attach the removable servicepanel 1972 to the handle housing 1974. In one aspect, the fasteners 1988in the removable service panel 1972 comprise a first set of magnets andthe handle housing 1974 comprises a second set of magnets thatmagnetically latch the service panel 1972 to the handle housing 1974. Inone aspect, the first and second set of magnets 6112 a, 6112 b arerare-earth permanent magnets.

In FIG. 70, the removable service panel 1972 is shown removed from thehandle housing 1974 to show the location of electrical and mechanicalcomponents of the surgical instrument such as the motor 1976 andelectrical contacts 1984 to electrically couple the battery assembly orflexible circuits to the handle housing 1974. The motor 1976 and theelectrical contacts 1984 are also removable from the handle housing1974. The handle assembly 1970 also comprises a trigger 1982 and anactuation switch 1980, each of which is removable from the handlehousing 1974. As previously described, the removable trigger 1982 mayhave multiple stages of operation to close the jaw member, fire theknife, activate the ultrasonic transducer, activate the high-frequencycurrent, and/or open the jaw member. The actuation switch 1980 may bereplaced with multiple switches to activate different functions such as,for example, close the jaw member, fire the knife, activate theultrasonic transducer, activate the high-frequency current, and/or openthe jaw member. As shown in FIG. 70, the handle assembly 1970 includeselectrical contacts 1978 to electrically couple the handle assembly 1970to the shaft assembly, where the electrical contacts 1978 are removablefrom the handle housing 1974. The handle housing 1974 also defines aspace to receive a removable ultrasonic transducer assembly, ultrasonictransducer, ultrasonic transducer drive circuits, high-frequency currentdrive circuits, and/or display assembly, as previously discussed herein.

FIGS. 71-75 illustrate various aspects of the present disclosure that isdirected to multiple magnetic position sensors disposed along the lengthof a shaft assembly of any one of the surgical instruments 100, 480,500, 600, 1100, 1150, 1200 described herein in connection with FIGS.1-70. The magnetic position sensors disposed along the length of theshaft assembly are paired in different configurations allowing multiplesensors to detect a single magnet coupled to a shaft motion (e.g.,articulation, end effector rotation, jaw member opening/closing) inorder to determine a three dimensional position of the actuatingcomponent from a stationary reference plane and simultaneouslydiagnosing any error from external sources.

Aspects of the present disclosure are presented for a system andsurgical instrument configured to detect three dimensional position andchange in position of various parts using a series of magnets andsensors. In some aspects, a surgical instrument includes a handleassembly, a shaft coupled to the handle assembly and an end effectorcoupled to a distal end of the shaft. Multiple magnets may be fixedlycoupled to the shaft, while multiple sensors may also be coupled to theshaft and configured to determine a distance away from each of themultiple magnets. The shaft may be configured to move, such as rotate,translate, and/or articulate about an articulation joint. The magnetsmay be coupled to the shaft such that the magnets move along with howthe shaft moves. However, the sensors may be coupled to the shaft suchthat the sensors remain in a stationary position while the shaft moves.For example, the shaft may include an exterior shaft and an interiorshaft, such as a primary rotary driver, and the exterior shaft may beconfigured to move while the primary rotary driver does not. The magnetsmay be affixed to the exterior shaft and the sensors may be affixed tothe primary rotary driver or a portion therein. The sensors may detectchange in distances of three or more magnets as the shaft moves, forexample, which may be processed by a processor to determine a change inthree dimensional position of the shaft. The data of the sensors may betransmitted to a processor via a flexible circuit running on the insideof the primary rotary driver.

In some aspects, a portion of the series of sensors and magnets may beconfigured to detect translation or other movements of the end effector.For example, the end effector may include a pair of jaws, where at leastone of the jaws is configured to open and close via a clap arm coupledto a portion of the primary rotary driver. The clamp arm may ultimatelybe communicatively coupled to a portion of the handle assemblyconfigured to manipulate the end effector, such as a handle or atrigger. Pulling the trigger of the handle assembly may cause one ormore of the jaws to open or close at the end effector. One or more ofthe magnets may be affixed to a portion of the clamp arm that moves whenthe clamp arm is manipulated. One or more of the sensors may be affixedto a portion of the shaft near the end effector that does not move whenthe clamp arm is manipulated. Thus, the sensors may be configured todetect a change in distance of these magnets as the clamp arm ismanipulated, which may be processed by a processor to determine a changein movement of the jaws of the end effector. The data of the sensors maybe transmitted to a processor via a flexible circuit running on theinside of the primary rotary driver.

In some aspects, the system and surgical instrument may also beconfigured to determine an error condition of the surgical instrumentusing the series of magnets and sensors. For example, an error conditionmay occur if movement of the magnets is detected to exceed knowntolerances or thresholds based on the detections of one or more of thesensors. For example, the shaft of the surgical instrument may beconfigured to rotate only so far, and if the sensors detect a change inposition of one or more magnets that exceeds the known rotation orangle, then an error condition may be generated. As another example,positions of multiple magnets may be monitored, and if one of thepositions of the magnets is calculated to be inconsistent withcalculated positions of the other magnets, an error condition may begenerated.

Referring to FIG. 71, illustration 5100 shows an example system of shaftcontrol electronics interconnecting inside a portion of a handleassembly and shaft assembly of a medical device such as any one of thesurgical instruments 100, 480, 500, 600, 1100, 1150, 1200 describedherein in connection with FIGS. 1-70, according to various aspects. Amodule 5102 shows a portion of the inner workings of a handle assemblythat is coupled to a module 5104 that comprises portions of a shaftassembly, according to some aspects. The module 5102 includes a flexiblecircuit 5106 that runs through a portion of the handle assembly and intothe shaft assembly. More specifically, in some aspects, the flexiblecircuit 5106 runs through a primary rotary driver 5108. The primaryrotary driver 5108 is configured to drive rotation of at least a portionof the shaft assembly. While the primary rotary driver 5108 runscontiguously through a portion of the handle assembly and the proximalend of the shaft assembly, in this illustration, a portion of theprimary rotary driver is not shown to reveal the flexible circuit 5106inside.

The proximal end of the flexible circuit 5106 may be coupled to anelectric contact 5110, which touches electrical contact points 5112 atthe handle. A gear 5138 of the primary rotary driver 5108 may be coupledto a rotating gear 5140 in the handle assembly that is driven by thehandle 5136. The electric contact 5110 and contact point 5112electrically couple the sensors 5126, 5128, 5130 to the control circuitssuch as control circuits 210 (FIG. 14), 300 (FIG. 15), 1300 (FIG. 62),1400 (FIG. 63), 1500 (FIG. 64), 1900 (FIG. 68A), 1910 (FIG. 68B), 1920(FIG. 68C), 1954 (FIG. 70), for example.

The distal end of the shaft assembly 5104 may be coupled to an endeffector, which may include one or more jaws mechanically andelectrically coupled at connector 5134. The flexible circuit 5106 may beconfigured to transmit electrical signals to the end effector via theconnector 5134.

Still referring to the shaft assembly 5104, the primary rotary driver5108 may be placed inside an exterior shaft 5114, according to someaspects. The primary rotary driver 5108 may be configured to rotate theexterior shaft 5114 while the flexible circuit 5106 remains stationary.In some aspects, the shaft assembly 5104 may also include a distal pieceof an exterior shaft 5116 that is coupled to the proximal exterior shaft5114 via an articulation joint 5118. While the primary rotary driver5108 may run only through the end of the proximal exterior shaft 5114,the flexible circuit 5106 may run through the distal exterior shaft5116, and may be configured to articulate and bend as the exterior shaft5116 articulates about the articulation joint 5118.

In some aspects, the exterior shaft portions of the shaft assembly 5104may include one or more magnets, such as magnets 5120, 5122, 5124. Thesemagnets may be affixed to the exterior shaft portions, and thus may moveor change position as the exterior shaft portions move or changeposition. Meanwhile, the flexible circuit 5106 may include one or moresensors configured to measure distance away from one or more magnets,such as sensors 5126, 5128, 5130. A Hall effect sensor is an exampletype of sensor configured to measure a distance away from one or moremagnets. As shown, the shaft assembly 5104 may include sets ofsensor-magnet pairs in close proximity to each other, such as the sensor5126 being in close proximity to the magnet 5120, the sensor 5128 beingin close proximity to the magnet 5122, and the sensor 5130 being inclose proximity to the magnet 5124. This configuration may allow thesensors to measure distances to only those magnets in close proximity.

In some aspects, the shaft assembly 5104 may also include a translatingshaft portion, such as the shaft portion 5132 configured to slide backand forth at the distal end of the shaft assembly 5104. The magnet 5124may be configured to translate or slide along with the shaft portion5132, while the sensor 5130 remains stationary, as it is attached to theflexible circuit 5106.

In some aspects, one or more of the sensor-magnet pairs may beconfigured to measure a degree of rotation of the shaft assembly 5104.For example, as the magnet 5120 rotates along with the exterior shaft5114, the change in distance away from the sensor 5126 may be measured.Based on the distance or the change in distance over time, it may bedetermined how much the exterior shaft 5114 has rotated.

Similarly, in some aspects, one or more of the sensor-magnet pairs maybe configured to measure a degree of articulation of the shaft assembly5104. For example, as the magnet 5122 articulates along with the distalexterior shaft portion 5116 about the articulation joint 5118, thesensor 5128 may be configured to measure a distance to the magnet 5122.Due to the placement of the sensor 5128 being slightly away from thecenter of the articulation joint 5118, the distance away from the magnet5122 will vary as the distal exterior shaft 5116 articulates. Based onthe distance or the change in distance over time, it may be determinedhow the distal exterior shaft 116 is articulating about the articulationjoint 5118.

Furthermore, in some aspects, one or more of the sensor-magnet pairs maybe configured to measure an amount of translation of the shaft assembly5104. For example, as the magnet 5124 translates along with thetranslating portion of the shaft 5132, the sensor 5130 may be configuredto measure the distance away from the magnet 5124. Based on the distanceor change in distance over time, it may be determined how much the shaftassembly is translating away from the sensor 5130.

In some aspects, the computed positions or changes in positionsaccording to the techniques described herein may be compared topredetermined tolerances. For example, a microprocessor and memorywithin the handle assembly of the medical device may have a table ofdistances or tolerances that reflect maximum ranges of movement byvarious parts of the shaft assembly. If it is computed that one or moreof the magnets exceeds one of the values in this table, then an errorcondition may be set an alarm may be activated.

In some aspects, any or all of these techniques may be included in amedical device to measure and monitor changes in position of the shaftassembly. The illustration 5100 provides merely some examples of wherethe magnets and sensors may be positioned, but it may be readilyapparent to those of ordinary skill in the art how the magnets and thesensors may be positioned to achieve similar effects, and aspects arenot so limited.

Referring to FIG. 72, illustration 5100 provides an example of a zoomedin portion of the flexible circuit 5106, according to some aspects. Asshown, the flexible circuit may comprise a series of substrate layers5202. The layers may be flexible enough to bend and twist. Hall effectsensors 5204 and 5206, or other kinds of sensors configured to measuremagnet strength, may be affixed to the flexible circuit 5106, as shown.

Referring to FIGS. 73A and 73B, in some aspects, a plurality of sensorsmay be used in combination to measure and monitor movements of themedical device, according to some aspects. For example, as shown inillustration 5160 of FIG. 73A, a cross-sectional view of a portion ofthe shaft assembly shows the exterior shaft 5162 comprising one magnet5164. The interior shaft 5166 may include a flexible circuit 5174. Theflexible circuit 5174 may comprise three sensors 5168, 5170, and 5172,positioned at various distances away from the magnet 5164. The exteriorshaft portion 5162 may be configured to rotate while the interior shaft5166, or at least a portion thereof, may be stationary.

Referring to FIG. 73B, illustration 5180 shows a rotational movement ofthe exterior shaft. As shown, the magnet 5164 rotates along with theexterior shaft 5162. The angle of rotation is indicated by the arrow5182 in relation to the centerline 5176. Because the three sensors 5168,5170, and 5172, are positioned at varying distances away from the magnet5164, a trilateration calculation may be conducted using the threedifferent distances to the magnet 5164 to determine more unambiguously aposition of the magnet 5164 as it is being rotated. Based on thecalculated position, a degree or angle of rotation of the exterior shaft5162 may be determined.

In general, with three or more sensors, a three-dimensional position ofthe magnets may be determined, assuming that the three or more sensorsare positioned at uniquely different distances away from the magnet tobe measured. Therefore, the principles shown in illustrations 5100 and5180 may be used to measure other types of changes in position, such astranslation distances or articulation angles.

In some aspects, instead of or in addition to multiple sensors, multiplemagnets may be affixed to the moving portion of the shaft assembly, andthe one or more sensors may be configured to measure the multipledistances of the multiple magnets to determine a three-dimensionalposition that way.

Referring to FIG. 74, illustration 5190 provides another example of howmultiple sensors can be used to determine a three-dimensional positionof one or more magnets, according to some aspects. In this example, theshaft assembly includes two parts about an articulation joint 5198. Twosensors, 5192 and 5194, are positioned along a flexible circuit 5199 onone side of the articulation joint 5198. On the other side is a magnet5196 that is configured to move along with that portion of the shaftassembly as it articulates about the articulation joint 5198. The twosensors 5192 and 5194 may be sufficient to determine a uniquethree-dimensional position of the magnet 5196, because the range ofmotion of the magnet 5196 is limited to only one plane of motion thatremains on only one side of the multiple sensors. In general, number ofsensors or magnets sufficient for determining unambiguous positions orchanges in positions may be based on where the sensors in magnets arepositioned, as well as how many degrees of freedom are available for thevarious parts to move.

In some aspects, the sensors and/or magnets may be positioned withdifferent configurations. Spacing of position sensors and magnets allowsfor higher resolution associated with location. For instance, sensors onopposite sides could sense the same magnet at different times, ordifferent magnets would interact with sensors at different locationsalong travel. In addition, further resolution can be achieved throughpatterns of magnets. For instance, magnets can be spaced such thatsensing two magnets in quick succession on one side, followed by anothergroup on the other side signifies a different location than two in oneon one side followed by a number of magnets on the other side. This mayreduce the number of magnets or sensors required to achieve this effect.

Referring to FIG. 75, illustration 5200 shows a variation of a shaftassembly of a medical device that includes a seal to protect sensitiveelectronics, according to some aspects. In this case, the outside shaft5202 includes at least two inner tubular structures. The rotary drive5204 is still present and is enclosed by the outside shaft. Within thatis a tube 5206 with flanges 5208, such as a rubber tube with flanges.The flanges 5208 may be configured to pressed against the inside surfaceof the rotary shaft 5204 to form a seal. The seal may be airtight andwatertight. The tube 5206 may then house electronics and other materialssensitive to liquid or other exposure, such as the flexible circuit5210.

Aspects of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Various aspects may, in either or both cases, be reconditionedfor reuse after at least one use. Reconditioning may include anycombination of the steps of disassembly of the device, followed bycleaning or replacement of particular pieces, and subsequent reassembly.In particular, aspects of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, aspects of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, aspects described herein may be processed beforesurgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

While various details have been set forth in the foregoing description,it will be appreciated that the various aspects of the techniques foroperating a generator for digitally generating electrical signalwaveforms and surgical instruments may be practiced without thesespecific details. One skilled in the art will recognize that the hereindescribed components (e.g., operations), devices, objects, and thediscussion accompanying them are used as examples for the sake ofconceptual clarity and that various configuration modifications arecontemplated. Consequently, as used herein, the specific exemplars setforth and the accompanying discussion are intended to be representativeof their more general classes. In general, use of any specific exemplaris intended to be representative of its class, and the non-inclusion ofspecific components (e.g., operations), devices, and objects should notbe taken limiting.

Further, while several forms have been illustrated and described, it isnot the intention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

For conciseness and clarity of disclosure, selected aspects of theforegoing disclosure have been shown in block diagram form rather thanin detail. Some portions of the detailed descriptions provided hereinmay be presented in terms of instructions that operate on data that isstored in one or more computer memories or one or more data storagedevices (e.g. floppy disk, hard disk drive, Compact Disc (CD), DigitalVideo Disk (DVD), or digital tape). Such descriptions andrepresentations are used by those skilled in the art to describe andconvey the substance of their work to others skilled in the art. Ingeneral, an algorithm refers to a self-consistent sequence of stepsleading to a desired result, where a “step” refers to a manipulation ofphysical quantities and/or logic states which may, though need notnecessarily, take the form of electrical or magnetic signals capable ofbeing stored, transferred, combined, compared, and otherwisemanipulated. It is common usage to refer to these signals as bits,values, elements, symbols, characters, terms, numbers, or the like.These and similar terms may be associated with the appropriate physicalquantities and are merely convenient labels applied to these quantitiesand/or states.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing” or “computing” or“calculating” or “determining” or “displaying” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). Those having skill in the art will recognize that thesubject matter described herein may be implemented in an analog ordigital fashion or some combination thereof.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inone form, several portions of the subject matter described herein may beimplemented via an application specific integrated circuits (ASIC), afield programmable gate array (FPGA), a digital signal processor (DSP),or other integrated formats. However, those skilled in the art willrecognize that some aspects of the forms disclosed herein, in whole orin part, can be equivalently implemented in integrated circuits, as oneor more computer programs running on one or more computers (e.g., as oneor more programs running on one or more computer systems), as one ormore programs running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and or firmware would be wellwithin the skill of one of skill in the art in light of this disclosure.In addition, those skilled in the art will appreciate that themechanisms of the subject matter described herein are capable of beingdistributed as one or more program products in a variety of forms, andthat an illustrative form of the subject matter described herein appliesregardless of the particular type of signal bearing medium used toactually carry out the distribution. Examples of a signal bearing mediuminclude, but are not limited to, the following: a recordable type mediumsuch as a floppy disk, a hard disk drive, a Compact Disc (CD), a DigitalVideo Disk (DVD), a digital tape, a computer memory, etc.; and atransmission type medium such as a digital and/or an analogcommunication medium (e.g., a fiber optic cable, a waveguide, a wiredcommunications link, a wireless communication link (e.g., transmitter,receiver, transmission logic, reception logic, etc.), etc.).

In some instances, one or more elements may be described using theexpression “coupled” and “connected” along with their derivatives. Itshould be understood that these terms are not intended as synonyms foreach other. For example, some aspects may be described using the term“connected” to indicate that two or more elements are in direct physicalor electrical contact with each other. In another example, some aspectsmay be described using the term “coupled” to indicate that two or moreelements are in direct physical or electrical contact. The term“coupled,” however, also may mean that two or more elements are not indirect contact with each other, but yet still co-operate or interactwith each other. It is to be understood that depicted architectures ofdifferent components contained within, or connected with, differentother components are merely examples, and that in fact many otherarchitectures may be implemented which achieve the same functionality.In a conceptual sense, any arrangement of components to achieve the samefunctionality is effectively “associated” such that the desiredfunctionality is achieved. Hence, any two components herein combined toachieve a particular functionality can be seen as “associated with” eachother such that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated also can be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated also can be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components, and/or electrically interacting components,and/or electrically interactable components, and/or opticallyinteracting components, and/or optically interactable components.

In other instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present disclosure have been shown anddescribed, it will be apparent to those skilled in the art that, basedupon the teachings herein, changes and modifications may be made withoutdeparting from the subject matter described herein and its broaderaspects and, therefore, the appended claims are to encompass withintheir scope all such changes and modifications as are within the truescope of the subject matter described herein. It will be understood bythose within the art that, in general, terms used herein, and especiallyin the appended claims (e.g., bodies of the appended claims) aregenerally intended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should not be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to claims containing only one such recitation, even when thesame claim includes the introductory phrases “one or more” or “at leastone” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an”should typically be interpreted to mean “at least one” or “one ormore”); the same holds true for the use of definite articles used tointroduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“one form,” or “a form” means that a particular feature, structure, orcharacteristic described in connection with the aspect is included in atleast one aspect. Thus, appearances of the phrases “in one aspect,” “inan aspect,” “in one form,” or “in an form” in various places throughoutthe specification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory).

A sale of a system or method may likewise occur in a territory even ifcomponents of the system or method are located and/or used outside theterritory. Further, implementation of at least part of a system forperforming a method in one territory does not preclude use of the systemin another territory.

All of the above-mentioned U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications, non-patent publications referred to in this specificationand/or listed in any Application Data Sheet, or any other disclosurematerial are incorporated herein by reference, to the extent notinconsistent herewith. As such, and to the extent necessary, thedisclosure as explicitly set forth herein supersedes any conflictingmaterial incorporated herein by reference. Any material, or portionthereof, that is said to be incorporated by reference herein, but whichconflicts with existing definitions, statements, or other disclosurematerial set forth herein will only be incorporated to the extent thatno conflict arises between that incorporated material and the existingdisclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

Various aspects of the subject matter described herein are set out inthe following numbered clauses:

1. A system comprising: a surgical instrument comprising: a handleassembly; a shaft coupled to the handle assembly; a plurality of magnetsfixedly coupled to the shaft; a plurality of sensors coupled to theshaft and each configured to determine a distance away from one or moreof the plurality of magnets; and a processor communicatively coupled tothe plurality of sensors; wherein: the shaft is configured to changeposition relative to a stationary reference plane; one or more of theplurality of magnets are configured to change position corresponding tothe changed position of the shaft; one or more of the plurality ofsensors are further configured to determine a change in the distances ofthe one or more of the plurality of magnets relative to the one or moreof the plurality of sensors as the one or more magnets change position;and the processor is configured to determine a three dimensional changein position of the shaft by computing a three dimensional change inposition of the one or more magnets, using the change in the distancesdetermined by the one or more plurality of sensors.

2. The system of clause 1, wherein: the shaft comprises an articulationjoint, a first component and a second component of the shaft, the firstand the second components coupled about the articulation joint; thesecond component of the shaft is configured to articulate about thearticulation joint; a first magnet of the plurality of magnets isfixedly coupled to the second component of the shaft; a first sensor ofthe plurality of sensors is coupled to the first component of the shaft;the first sensor is configured to measure a change in distance away fromthe first magnet as the second component of the shaft is articulatedabout the articulation joint; and the processor is configured todetermine the three dimensional change in position of the articulationof the second component of the shaft using the measured change indistance of the first magnet away from the first sensor.

3. The system of clause 2, wherein: a second magnet of the plurality ofmagnets is fixedly coupled to the second component of the shaft at aposition different from where the first magnet is coupled to the secondcomponent; the first sensor is further configured to measure a change indistance away from the second magnet as the second component of theshaft is articulated about the articulation joint; and the processor isfurther configured to determine the three dimensional change in positionof the articulation of the second component of the shaft using themeasured change in distance of the first magnet away from the firstsensor and the measured change in distance of the second magnet awayfrom the first sensor.

4. The system of any one of clauses 1-3, wherein: the shaft comprises anexterior shaft and an inner shaft positioned within the exterior shaft;the inner shaft is configured to rotate within the exterior shaft; afirst magnet of the plurality of magnets is fixedly coupled to theexterior shaft; a first sensor of the plurality of sensors is fixedlycoupled to the inner shaft; the first sensor is configured to measure achange in distance away from the first magnet as the exterior shaft isrotated relative to the inner shaft; and the processor is configured todetermine a degree of rotation of the exterior shaft relative to theinner shaft using the measured change in distance of the first magnetaway from the first sensor.

5. The system of clause 4, wherein: a second magnet of the plurality ofmagnets is fixedly coupled to the exterior shaft at a position differentfrom where the first magnet is coupled to the exterior shaft; the firstsensor is further configured to measure a change in distance away fromthe second magnet as the exterior shaft is rotated relative to the innershaft; and the processor is further configured to determine the degreeof rotation of the exterior shaft using the measured change in distanceof the first magnet away from the first sensor and the measured changein distance of the second magnet away from the first sensor.

6. The system of any one of clauses 1-5, wherein: the surgicalinstrument further comprises an end effector coupled to a distal end ofthe shaft, the end effector comprising a pair of surgical jaws; theshaft comprises a clamp arm driver coupled to the pair of surgical jawsthat is configured to translate proximally and distally to manipulatemovement of the pair of surgical jaws; a first magnet of the pluralityof magnets is fixedly coupled to the clamp arm driver; a first sensor ofthe plurality of sensors is coupled to a portion of the shaft that doesnot translate when the clamp arm driver translates; the first sensor isconfigured to measure a change in distance away from the first magnet asthe clamp arm driver translates; and the processor is configured todetermine a distance of translation of the clamp arm driver using themeasured change in distance of the first magnet away from the firstsensor.

7. The system of clause 6, wherein: a second magnet of the plurality ofmagnets is fixedly coupled to the clamp arm driver at a positiondifferent from where the first magnet is coupled to the exterior shaft;the first sensor is further configured to measure a change in distanceaway from the second magnet as the clamp arm driver translates; and theprocessor is further configured to determine the distance of translationof the clamp arm driver using the measured change in distance of thefirst magnet away from the first sensor and the measured change indistance of the second magnet away from the first sensor.

8. The system of any one of clauses 1-7, wherein the processor isfurther configured to determine an error condition of the surgicalinstrument by measuring whether the change in the distances determinedby the one or more plurality of sensors fails to satisfy at least onepredetermined threshold.

9. The system of any one of clauses 1-8, wherein the surgical instrumentfurther comprises a flexible circuit configured to deliver an electricalconnection to a distal end of the shaft and articulate about anarticulation joint of the shaft.

10. The system of any one of clauses 1-10, wherein the surgicalinstrument further comprises a rotary driver communicatively coupled tothe handle assembly and configured to cause rotation of at least aportion of the shaft.

11. A surgical instrument, comprising: a plurality of magnets; aplurality of sensors configured to determine a distance away from one ormore of the plurality of magnets; and a processor communicativelycoupled to the plurality of sensors, wherein the processor is configuredto determine a three dimensional change in position of the surgicalinstrument by computing a three dimensional change in position of theone or more magnets, using the change in the distances determined by theone or more plurality of sensors.

12. The surgical instrument of clause 11, wherein the processor isconfigured to determine the three dimensional change in position of anarticulation of a component of the surgical instrument using themeasured change in distance of a first magnet away from a first sensor.

13. The surgical instrument of clause 11 or 12, wherein the processor isconfigured to determine a degree of rotation of an exterior component ofthe surgical instrument relative to an inner component of the surgicalinstrument using the measured change in distance of a first magnet awayfrom a first sensor.

14. The surgical instrument of any one of clauses 11-13, wherein theprocessor is configured to determine a distance of translation of acomponent of the surgical instrument using the measured change indistance of the first magnet away from the first sensor.

15. The surgical instrument of any one of clauses 11-14, wherein theprocessor is further configured to determine an error condition of thesurgical instrument by measuring whether the change in the distancesdetermined by the one or more plurality of sensors fails to satisfy atleast one predetermined threshold.

16. The surgical instrument of any one of clauses 11-15, wherein thesurgical instrument further comprises a flexible circuit configured todeliver an electrical connection to a portion of the surgicalinstrument.

17. The surgical instrument of any one of clauses 11-16, wherein thesurgical instrument further comprises a rotary driver and configured torotate of at least a portion of the surgical instrument.

18. A method of controlling a surgical instrument comprising a pluralityof magnets, a plurality of sensors configured to determine a distanceaway from one or more of the plurality of magnets, and a processorcommunicatively coupled to the plurality of sensors, the methodcomprising: determining, by the processor, a three dimensional change inposition of the surgical instrument by computing a three dimensionalchange in position of the one or more magnets, using the change in thedistances determined by the one or more plurality of sensors.

19. The method of clause 18, wherein the method comprises: determining,by the processor, the three dimensional change in position of anarticulation of a component of the surgical instrument using themeasured change in distance of a first magnet away from a first sensor.

20. The method of clause 18 or 19, wherein the method comprises;determining, by the processor, a degree of rotation of an exteriorcomponent of the surgical instrument relative to an inner component ofthe surgical instrument using the measured change in distance of a firstmagnet away from a first sensor.

21. The method of any one of clauses 18-20, wherein the methodcomprises: determining, by processor, a distance of translation of acomponent of the surgical instrument using the measured change indistance of the first magnet away from the first sensor.

22. The method of any one of clauses 18-21, wherein the methodcomprises: determining, by the processor, an error condition of thesurgical instrument by measuring whether the change in the distancesdetermined by the one or more plurality of sensors fails to satisfy atleast one predetermined threshold.

The invention claimed is:
 1. A surgical instrument, comprising: a shaftassembly comprising a plurality of magnets; a flexible circuitpositioned within the shaft assembly, the flexible circuit comprising aresistor, a capacitor, an inductor, and a series of substrate layersthat are flexible enough to bend or twist, the series of substratelayers spanning the entirety of the flexible circuit; a plurality ofsensors positioned on the flexible circuit within the shaft assembly andconfigured to determine a distance away from one or more of theplurality of magnets; and a processor communicatively coupled to theplurality of sensors, wherein the processor is configured to: measure achange in distances between the plurality of sensors and the one or moreof the plurality of magnets after a component of the surgical instrumentmoves with respect to the flexible circuit on which the plurality ofsensors are positioned, using the plurality of sensors, wherein thecomponent comprises a portion of the shaft assembly having the pluralityof magnets; and determine a three dimensional change in position of thesurgical instrument by computing a three dimensional change in positionof the one or more of the plurality of magnets, using the change in thedistances determined by the plurality of sensors, wherein the shaftassembly comprises an articulation joint and the shaft assembly isconfigured to articulate about the articulation joint, wherein a firstsensor among the plurality of sensors and a first magnet among theplurality of magnets are disposed adjacent the articulation joint, andwherein the first sensor is placed away from a center of thearticulation joint so that a distance from the first sensor to the firstmagnet changes as the shaft assembly articulates.
 2. The surgicalinstrument of claim 1, wherein the processor is configured to determinea three dimensional change in position of an articulation of thecomponent of the surgical instrument using the measured change indistances of the one or more of the plurality of magnets away from theplurality of sensors.
 3. The surgical instrument of claim 1, wherein thecomponent is an exterior component of the surgical instrument, andwherein the processor is configured to determine a degree of rotation ofthe exterior component of the surgical instrument relative to an innercomponent of the surgical instrument using the measured change indistances of the one or more of the plurality of magnets away from theplurality of sensors, wherein the inner component comprises a portion ofthe flexible circuit.
 4. The surgical instrument of claim 1, wherein theprocessor is configured to determine a distance of translation of thecomponent of the surgical instrument using the measured change indistances of the one or more of the plurality of magnets away from theplurality of sensors.
 5. The surgical instrument of claim 1, wherein theprocessor is further configured to determine an error condition of thesurgical instrument by measuring whether the change in the distancesdetermined by the plurality of sensors fails to satisfy at least onepredetermined threshold.
 6. The surgical instrument of claim 1, whereinthe flexible circuit is configured to deliver an electrical connectionto a portion of the surgical instrument.
 7. The surgical instrument ofclaim 1, wherein the surgical instrument further comprises a rotarydriver and configured to rotate at least a portion of the surgicalinstrument.
 8. The surgical instrument of claim 1, wherein the pluralityof magnets are positioned externally on the shaft assembly.
 9. Thesurgical instrument of claim 1, wherein: one magnet among the pluralityof magnets and one sensor among the plurality of sensors forms amagnet-sensor pair; the shaft assembly is configured to rotate about alongitudinal axis centered within the shaft assembly; and themagnet-sensor pair is configured to measure a degree of rotation of theshaft assembly as the shaft assembly rotates.
 10. The surgicalinstrument of claim 1, wherein: one magnet among the plurality ofmagnets and one sensor among the plurality of sensors forms amagnet-sensor pair; the shaft assembly is configured to translate in aproximal and a distal direction; and the magnet-sensor pair isconfigured to measure a length of translation of the shaft assembly asthe shaft assembly translates.
 11. A method of controlling a surgicalinstrument comprising a shaft assembly that comprises a plurality ofmagnets, a flexible circuit positioned within the shaft assembly, aplurality of sensors positioned on the flexible circuit and configuredto determine a distance away from one or more of the plurality ofmagnets, and a processor communicatively coupled to the plurality ofsensors, wherein the flexible circuit comprises a resistor, a capacitor,an inductor, and a series of substrate layers that are flexible enoughto bend or twist, the series of substrate layers spanning the entiretyof the flexible circuit, the method comprising: changing, by thesurgical instrument, a position in a first component of the surgicalinstrument relative to a second component of the surgical instrument,wherein the first component comprises a portion of the shaft assemblyhaving the plurality of magnets and the second component comprises aportion of the flexible circuit on which the plurality of sensors arepositioned; and in response, determining, by the processor, a threedimensional change in position of the surgical instrument by computing athree dimensional change in position of the one or more magnets, using achange in the distances determined by the plurality of sensors, whereinthe shaft assembly comprises an articulation joint and the shaftassembly is configured to articulate about the articulation joint,wherein a first sensor among the plurality of sensors and a first magnetamong the plurality of magnets are disposed adjacent the articulationjoint, wherein the first sensor is placed away from a center of thearticulation joint so that a distance from the first sensor to the firstmagnet changes as the shaft assembly articulates, and wherein the methodfurther comprises measuring, by the first sensor, a degree ofarticulation of the shaft assembly by measuring the distance from thefirst sensor to the first magnet.
 12. The method of claim 11, whereinthe first component is an exterior component and the second component isan inner component, wherein the method further comprises: determining,by the processor, a degree of rotation of the exterior component of thesurgical instrument relative to the inner component of the surgicalinstrument using a measured change in distance of a second magnet amongthe plurality of magnets away from a second sensor among the pluralityof sensors.
 13. The method of claim 11, further comprising: determining,by the processor, a distance of translation of the first component ofthe surgical instrument using a measured change in distance of a secondmagnet among the plurality of magnets away from a second sensor amongthe plurality of sensors.
 14. The method of claim 11, furthercomprising: determining, by the processor, an error condition of thesurgical instrument by measuring whether the change in the distancesdetermined by the plurality of sensors fails to satisfy at least onepredetermined threshold.